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Bio Sud Medical Systems
Italian manufacturer of surgical sutures and medical devices

Italian manufacturer of surgical sutures and medical devices

Product catalog summary

About the Company
BIO SUD MEDICAL SYSTEMS Srl, founded in 1984, is an Italian manufacturer specializing in medical devices, including surgical sutures. The company operates from a modern facility in Bari, Italy, and holds ISO 13485 and ISO 9001 certifications, ensuring high-quality management and production processes. The company prioritizes customer satisfaction, quality products, and competitive pricing.

Production and Quality Assurance
BIOMED® products are manufactured in a certified clean room in Italy, with rigorous quality checks and validated production processes. The company emphasizes technological innovation and uses advanced automation to maintain high and repeatable quality standards. All products are CE 0373 certified.

Product Range
The BIOMED® product line includes absorbable and non-absorbable sutures, as well as other surgical devices like pledgets, loops, incision drapes, and dressings. The sutures are customizable to meet specific customer needs.

Needles and Sutures
BIOMED® uses high-quality siliconized steel needles known for their ductility, flexibility, and resistance to breakage. The needles are drilled-end type, providing better needle/thread seal and reducing trauma during surgical procedures. The sutures are designed to minimize tissue trauma and are available in various packaging options to suit different surgical needs.

Packaging and Labeling
Sutures are packaged to reduce memory effect and ensure traceability. Each package includes detailed information about the suture, such as product name, needle specifications, thread size, and expiration date.

Product Specifications
The document provides detailed specifications for various suture types, including BIOSHORT, an absorbable synthetic monofilament suture. BIOSHORT is available in different colors and sizes, with specific tensile strength and absorption rates. It is suitable for various surgical applications but not recommended for cardiovascular or ophthalmic surgeries.

Conclusion
BIO SUD MEDICAL SYSTEMS Srl is committed to providing high-quality medical devices with a focus on innovation, quality, and customer satisfaction. Their extensive range of products and adherence to international standards make them a reliable partner in the medical field.

Glyco Sutures Overview
The document provides detailed specifications and information about Glyco braided and coated absorbable synthetic sutures. These sutures are designed for soft tissue approximation and ligation, including ophthalmic procedures, but their safety in cardiovascular and neural tissues is not defined.

Specifications

Material: Polyglycolic acid (PGA) with a coating of polycaprolactone and calcium stearate.
Color: Available in violet or undyed (beige).
Tensile Strength: Maintains approximately 82% of its strength after two weeks and 56% after three weeks post-implantation.
Absorption: Complete absorption occurs through hydrolysis within 60 to 90 days.
Sterilization: Ethylene oxide.
Expiration: 5 years.

Key Features

High tensile strength and easy handling.
Excellent knot tying security and tissue sliding.
Predictable absorption profile.

Certification
CE 0373 class III.

Product Range
The document lists various suture specifications, including gauge, thread length, pack size, and specific codes for different types of sutures, such as round-bodied, blunt point, taper cut, and reverse cutting needles. Each type is available in multiple sizes and colors, with specific codes for easy identification.

Biocryl Sutures Overview
The document provides detailed specifications for GLYCO and BIOCRYL braided and coated absorbable synthetic sutures. These sutures are used for soft tissue approximation and ligation, including ophthalmic procedures. The document outlines various types of sutures, their sizes, and specific codes.

Specifications
The sutures are available in different gauges and lengths, with options for violet or undyed colors. They are made from a glycolic acid copolymer (90%) and lactic acid (10%), known as Polyglactin 910, and coated with Polyglactin 370 and calcium stearate. The sutures maintain high tensile strength, easy handling, and excellent knot security.

Absorption and Sterilization
Absorption occurs through hydrolysis, completing in 56-70 days. Sutures are sterilized using ethylene oxide and have a shelf life of 5 years.

Performance
Biocryl sutures retain approximately 75% of their tensile strength after two weeks, 50% after three weeks, and 30% after four weeks for USP 4/0 sutures. The document includes a graph illustrating the tensile strength retention over time.

Certification
The sutures are CE 0373 class III certified.

Product Variants
The document lists various suture types, including reverse cutting, round-bodied, loop sutures, atraumatic spatula, and taper cut, each with specific codes and packaging details.

Limitations
The safety and effectiveness of Biocryl sutures in cardiovascular and neural tissues have not been defined.

Biocryl Rapid Overview
This section highlights the Biocryl Rapid sutures, which are short-term absorbable and made from a glycolic acid copolymer. They are designed for rapid absorption, making them suitable for pediatric surgery, episiotomies, circumcisions, and oral mucosa wounds. The sutures maintain 60-70% tensile strength after five days and are fully absorbed in about 42 days.

Certification and Sterilization
The sutures are CE certified (class III) and sterilized using ethylene oxide. They have a shelf life of five years.

Applications
The document suggests that Biocryl Rapid sutures are ideal for soft tissue approximation where short wound support is needed. They are also suitable for ophthalmic surgery.

Key Data
The document includes tables with detailed product codes, sizes, and configurations, providing a comprehensive guide for selecting the appropriate suture for specific surgical needs.

BIOLONG® and BIOLENE Sutures Overview
The document provides detailed specifications for BIOLONG® and BIOLENE sutures, focusing on their types, sizes, and specific codes. These sutures are designed for various medical applications, including wound closure and surgical procedures.

BIOLONG® Sutures

Type: Barbed, round-bodied, and available in different needle shapes (1/2 circle, 5/8 circle, straight, ski).
Material: Absorbable synthetic monofilament.
Features: Knotless wound closure device, available in various gauges and thread lengths.
Specifications: Includes USP and EP codes, with specific codes for each suture type and size.

BIOLENE Sutures

Type: Non-absorbable synthetic monofilament, round-bodied, available in 1/2 circle and 3/8 circle needle shapes.
Material: Polypropylene, available in blue or undyed.
Features: High tensile strength, easy handling, excellent knot tying security, and low thread memory.
Applications: Suitable for soft tissue approximation and ligation, cardiovascular surgery, neurosurgery, skin closure, and plastic surgery.
Specifications: Includes USP and EP codes, with specific codes for each suture type and size.
Certification: CE 0373 class III.

Key Data

Thread Lengths: Vary from 15 cm to 150 cm depending on the suture type and application.
Gauge Sizes: Range from 7/0 to 1, with different tensile strengths and applications.
Packaging: Offered in dedicated packaging to prevent memory effect, with a shelf life of 5 years.

BIOLENE and NOVABIO Sutures Overview
The document provides detailed specifications for BIOLENE and NOVABIO non-absorbable synthetic monofilament sutures. These sutures are used in various surgical procedures, including cardiovascular, neurosurgery, and ophthalmic surgeries.

Specifications
The sutures are categorized based on their needle type (e.g., round-bodied, reverse cutting), circle size (e.g., 3/8, 1/2), and gauge. Each entry includes the thread length, pack size, and specific code for identification. The sutures are available in different diameters and lengths, tailored for specific surgical needs.

Key Features

High tensile strength and flexibility for easy handling and knot security.
Smooth surface for atraumatic passage through tissues.
Low thread memory, ensuring ease of use during procedures.

Applications
Novabio sutures are particularly suitable for minimally invasive procedures in vascular and cardiac surgeries due to their long durability. They are also indicated for suturing blood vessels and soft tissues.

Technical Details

Material: Polyvinylidenfluoride
Coating: Uncoated
Sterilization: Ethylene oxide
Expiry: 5 years
Certification: CE 0373 class III

Conclusion
The document provides comprehensive information on the types and specifications of BIOLENE and NOVABIO sutures, emphasizing their high performance and suitability for critical surgical applications.

POLYBIO Sutures Overview
The document provides detailed specifications for POLYBIO braided and coated non-absorbable synthetic multifilament sutures. These sutures are categorized based on their needle shape, gauge, thread length, and specific codes. The document includes various types of sutures such as round-bodied, taper cut, reverse cutting, and others, each with specific applications and characteristics.

Specifications
The sutures are available in different needle shapes including 1/2 circle, 3/8 circle, 5/8 circle, J needle, straight, and bicurve. Each type is further detailed with gauge sizes, thread lengths, and packaging information. The sutures are color-coded, primarily in green, with some variations in white and black.

Key Features
The sutures are noted for their high tensile strength, flexibility, and ease of handling. They are designed for various surgical applications, including uterus surgery using the Shirodkar, McDonald, and Wurm-Hefner methods. The document also mentions specific sutures for atraumatic spatula and sterile pre-cut sutures on spools.

Applications
The sutures are suitable for a range of surgical procedures, with specific types recommended for uterus surgery and other specialized applications. The document provides detailed codes for each suture type, facilitating easy identification and selection for specific surgical needs.

Materials and Colors
The sutures are made from polyamide 6 or polyamide 6-6, available in blue or black colors. They are uncoated, which contributes to their high tensile strength and ease of use.

Medical Products Overview
The document provides detailed specifications and descriptions of various medical products, including sutures, pledgets, surgical laces, drapes, dressings, and absorbent pads. These products are primarily used in surgical procedures and are manufactured by Bio Sud Medical Systems under the BIOMED® trademark.

Sutures
The document lists BIOSILK braided and coated non-absorbable natural sutures, available in various sizes and specifications. These sutures are designed for different surgical needs, with details on gauge, thread length, and specific codes for identification.

Biofelt Pledgets
Biofelt pledgets are made of PTFE and are used to reinforce sutures and support tissue load. They are available in soft and hard types, with various sizes and configurations, including options with holes for specific procedural requirements.

Bioloop Surgical Laces
Bioloop products include silicone and cotton surgical laces used for organ suspension and differentiation. They are available in various colors and sizes, with options for blunt point needles.

Bioincise Drape
Bioincise is a polyurethane film drape used for surgical incisions, providing a barrier against contamination. It is available in multiple sizes and is latex-free.

Bioproof Dressing
Bioproof is a waterproof adhesive dressing that allows skin transpiration and provides protection against water and contaminants. It is available in several versions, including those with and without pads.

Biodress and Bioptical Dressings
Biodress is a sterile dressing made of non-woven fabric, while Bioptical is designed for eye protection post-surgery. Both products are hypoallergenic and latex-free.

Tracheotomy and Drain Absorbent Pads
These pads, including BIODRENPAD and BIOTRAC, are designed for tracheotomy and drainage applications, providing absorbency and protection against bacterial contamination.

Company Information
Bio Sud Medical Systems is an Italian manufacturer of surgical sutures and medical devices, certified by ISO standards and the ISS. The company emphasizes high-quality production and global sourcing of materials.

Catalog excerpts

Italian manufacturer of surgical sutures and medical devices-1

O E BI M D Italian manufacturer of surgical sutures and medical devices

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Italian manufacturer of surgical sutures

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BIO SUD MEDICAL SYSTEMS Srl is an Italian company that produces medical devices. The company was established in 1984 gaining many years of experience in the biomedical sector and working with multinational companies, manufacturers of hospital items. The production site is located in the new and modern settlement in the industrial district of Bari, with an area of approximately 2750 m2: 500 m2 of these are used as offices, 250 m2 as Clean Room reserved to the production and approximately 2000 m2 as warehouse use. Currently, BIO SUD MEDICAL SYSTEMS Srl is able to provide a wide range of medical...

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Italian manufacturer of surgical sutures and medical devices-5

BIOMED®’s modern production activity takes place entirely in Italy, inside a clean room certified according to ISO standards and under constant control of the cleaning parameters. The strategies are designed in order to obtain high quality products, through a careful global selection of both raw material suppliers and machinery. The production processes are validated and subjected to constant checks with the support of laboratory activities. All BIOMED® products are certified with CE 0373 marking and can rely on a considerable technological know-how, in order to achieve an high and constantly...

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For all BIOMED® sutures, 300 series siliconized steel needles are used, the best solution on the market for its characteristics of ductility, flexibility, penetration and resistance to breakage. Furthermore, all the needles are drilled-end and not channel-end type: they have a hole in the terminal part where the thread is inserted, guaranteeing both a better needle/thread seal during the stresses in surgical practices, and a greater uniformity of the body of the suture greatly reducing bleeding due to more traumatic passages. The high quality of the needles used for BIOMED® sutures allows these...

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Italian manufacturer of surgical sutures and medical devices-7

Italian manufacturer of surgical sutures The Surgical Needles Needle Shapes legend 1/2 c Needle Tips legend ROUND BODIED BLUNT POINT REVERSE CUTTING REVERSE CUTTING PRECISION POINT Ski ROUND BODIED PLUS ATRAUMATIC SPATULA

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Italian manufacturer of surgical sutures and medical devices-8

The welding between needle and thread necessarily involves a deformation of the needle as it is mechanically forced in order to guarantee the tightness of the thread even where strong tractions are applied on the suture. The BIOMED® sutures are subjected to a process of shrinking the needle attaching area which guarantees the least possible deformation and at the same time compliance with all the standards prescribed by the pharmacopoeia. A great deal of attention is paid to the choice of needles so that the ratio is as close as possible to 1:1 between the outer diameter of the needle and that...

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Italian manufacturer of surgical sutures DIFFERENT PACKAGINGS Different types of packaging accompany our sutures according to the specific surgery to which they are produced. A particular attention is paid to cardiac and vascular surgery where are used packaging which allow a considerable reduction of the memory effect of the monofilament and polyester multipack for valve replacement procedures. The characteristics of the suture are reproduced on each packaging, from the external box up to the single sterile punch, to guarantee complete traceability and, at the same time, facilitating its identification....

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BIOMED® LABELING LEGEND 1 2 Description of the suture molecule Needle length Product name Shape and size of the needle scale 1: 1 Manufacturer information (EUROPEAN PHARMACOPOEIA) Batch number Expiration date ISO regulation symbols Sutura chirurgica non assorbibile in Poliammide 6-6/6, monofilamento, blu Non-absorbable surgical suture in Polyamide 6-6/6, monofilament, blue Bio Sud Medical Systems S.r.l. Via dei Fabbri, 23/25 - 70026 - Modugno (BA) - Italia Bio Sud Medical Systems S.r.l. Via dei Fabbri, 23/25 - 70026 Modugno (BA) - Italia GS1 Data Matrix code MM/YYYY YY/XXXXXXX Number of sutures...

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Italian manufacturer of surgical sutures THREADS SYMBOLS USED ON PACK Absorbable Suture Product name dyed - braided - coated - absorbable undyed - braided - coated - absorbable BIOCRYL / GL YCO / BIOCRYL RAPID dyed - monofilament - absorbable BIOSHORT / BIOLONG undyed - monofilament - absorbable BIOSHORT / BIOLONG dyed - monofilament - barbed - absorbable BIOSHORT / BIOLONG undyed - monofilament - barbed - absorbable Nonabsorbable Suture Product name dyed - braided - coated - nonabsorbable undyed - braided - coated - nonabsorbable dyed - monofilament - nonabsorbable BIOLENE / NOVABIO / NYLON...

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Italian manufacturer of surgical sutures

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INDEX ABSORBABLE SUTURES: BIOSHORT BIOSHORT BARBED BIOCRYL RAPID BIOLONG BARBED NON-ABSORBABLE SUTURES: BIOLENE

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INDEX MEDICAL DEVICES FOR SURGERY: BIOFEL T TRACHEOTOMY AND DRAIN ABSORBENT PADS

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Absorbable synthetic monofilament suture COLOR Violet or undyed (amber) MOLECULE Copolymer composed of 75% Glycolide and 25% ε-caprolactone (PGA-PCL) COATING TYPE Uncoated SPECIFICS • High tensile strength. • Easy handling, flexibility and easy execution of the node. • Atraumatic passage through the tissues due to the smooth surface. • Excellent sliding through the tissues. • Low thread memory. SUTURE TENSILE STRENGTH COLORED: 70% in one week; 40% in two weeks; 12% in three weeks; 3% in four weeks. UNCOLORED: 80% in one week; 40% in two weeks; 15% in three weeks; 4% in four weeks. colored uncolored...

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