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GC-15/5 Ultrasound transmission gel transparent

GC-15/5 Ultrasound transmission gel transparent

GC-15/5 Ultrasound transmission gel transparent

Product catalog summary
Product Description
Ultrasound transmission gel is used as a medium for acoustically coupling a transducer to the human body during ultrasound imaging procedures. It is applied to the patient's skin or the transducer before starting the examination.
Product Characteristics
  • Non-irritating to skin
  • Non-greasy and hydrosoluble
  • Free from salt, natural latex, phthalates, and animal-derived compounds
  • High density, spreads easily and uniformly
Technical Specifications
  • Ingredients: Aqua, Glycerin, Carbomer, Propylene Glycol, Sodium Hydroxide, Diazolidinyl Urea, Methylparaben, Disodium EDTA, Propylparaben
  • Packaging materials: Various types of polyethylene and polypropylene
  • Physio-chemical properties: Colorless, transparent, viscous gel with a density of 1.00 – 1.02 g/mL and pH of 5.5-6.5
  • Microbiological properties: Low levels of aerobes, molds, and yeasts; absence of pathogens
  • Biocompatibility: Non-cytotoxic, non-sensitizing, and no intracutaneous irritation
Sterilization and Expiry Date
  • Non-sterile product with a shelf life of 3 years
  • Recommended to use within one day after opening, but safe for 30 days if stored properly
Storage and Maintenance
  • Store in a cool, dry place away from direct sunlight
  • Temperature range: 5-40°C
  • Single-use product with no maintenance required
Packaging
  • Available in various sizes: 250 mL, 500 mL, 1L, and 5L containers
Instructions for Use
  • Apply on the selected area and remove with a disposable towel
Regulatory Information
  • Conforms to Regulation (UE) 2017/745 and UK MDR Regulation 2002 on Medical Devices
  • Class I product according to relevant regulations
  • GMDN code: 15321, EMDN code: 711040185
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Catalog excerpts

GC-15/5 Ultrasound transmission gel transparent-1

DATA SHEET Ultrasound transmission gel transparent Transonic > Product description Ultrasound gels are intended for general use as a transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. Product charasteristics « Does not irritate skin. ¢ Non greasy. « Hydrosoluble. « Does not contain salt. Does not damage the transducer. « High density. It spreads out easily and uniformly. « This product is free to natural latex, phthalatos and animal or biological origin compounds. Technical specifications Ingredients Aqua (Water), Glycerin, Carbomer, Propylene Glycol, Sodium Hydroxide, Diazolidinyl Urea, Methylparaben, Disodium EDTA Propylparaben. Materials ¢ 250 mL white bottle: PEHD ¢ 500 mL white bottle: HDPE o 1L white bottle: PEHD o 5L flexible container: LLDPE ¢ 5L rigid container: HDPE This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allowed 1-3

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GC-15/5 Ultrasound transmission gel transparent-2

TECHNICAL DATA SHEET ¢ Tube: Polyethylene PE BD o Push-button: PP « Bagel: PP Physio-chemical proprieties « Colour, Odour, Appearance: Colourless gel, transparent, viscous. Odour to its raw materials (it doesn’t contain perfume) « Density: 1.00 — 1.02 g/mL (202C) ¢ pH:55-6.5 o Viscosity (222C): >1.000.000 mPa-s ¢ Acoustic impedance: 1.63 MRayls « Efficiency (from 0.5 MHz): > 99.5% Microbiological properties « Total aerobes: <10 UFC/mL » Moulds and yeasts: <10 UFC/mL « Pathogens (Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, Escherichia coli): Absence Biocompatibility ¢ ISO...

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GC-15/5 Ultrasound transmission gel transparent-3

TECHNICAL DATA SHEET TELIC GROUP ¢ 5L containers: Security guaranteed for one month, always if good practices are maintained: refill working bottles and put the cap on immediately. Store in a cool and dry place. Keep away from direct sunlight. Disinfect any compound (cannule, dosing pump) before putting in contact with gel Storage and maintenance + Keep protected from direct sunlight / the outside « Keep ina dry place ¢ Temperature range: 5-402C « Single use product. No maintenance required 1L bottle: Service box of 20 units. 500 mL bottle: Service box of 20 units. 5L flexible container with...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.