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Telic Group
GC-15/E Sterile ultrasound transmission gel

GC-15/E Sterile ultrasound transmission gel

Product catalog summary

Product Overview
Sterile ultrasound gel, known as Transonic, is designed for use as a transmission medium in ultrasound imaging procedures. It ensures effective acoustic coupling between the transducer and the patient's skin, suitable for both diagnostic and therapeutic applications where sterility is required.

Technical Specifications

Non-irritating, non-greasy, and hydrosoluble.
Free from salt, natural latex, phthalates, and animal-derived compounds.
Spreads easily and uniformly without damaging the transducer.

Ingredients
The gel is composed of water, propylene glycol, carbomer, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben, and disodium EDTA.

Packaging

Sachet: PET/Pet-metalized/PE film.
Thermo-sealed pouch: Medical-grade cellulose paper and transparent PA/PP film.

Physico-chemical Properties

Appearance: Colourless or slightly yellowish, transparent, and viscous.
Density: 1.00 – 1.02 g/ml.
pH: 5.8 – 6.4.
Viscosity at 22ºC: >1,300,000 cps.
Acoustic impedance: 1.62 MRayls.
Efficiency: >99.5% from 0.5MHz.

Microbiological and Biocompatibility Properties

Sterile according to EN 556-1 standard.
Biocompatible: Non-cytotoxic, non-sensitizing, and non-irritant as per ISO 10993 standards.

Sterilization and Expiry

Sterilized by radiation.
Shelf life: 2 years from manufacturing date.

Storage and Maintenance

Store away from direct sunlight in a dry place.
Temperature range: 5-40ºC.
Single-use product with no maintenance required.

Instructions for Use

Apply over the selected area and remove with a disposable towel.

Regulatory Information

Conforms to Regulation (UE) 217/745 and ISO 13485 certified Quality Assurance System.
Classified as Class I sterile product under Regulation (UE) 2017/745.
GMDN code: 58735 – Coupling gel, sterile.
EMDN code: Z11040185 (Ultrasound scanners-consumables).

Catalog excerpts

GC-15/E Sterile ultrasound transmission gel-1

TECHNICAL DATA SHEET Ultrasound transmission sterile gel Transonic Product description Sterile ultrasound gel is 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. The sterile product is recommended for diagnostic and therapeutic ultrasound applications when sterility is indicated. Does not irritate skin. Does not contain salt. Does not damage the transducer. 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), Propylène Glycol, Carbomer, Sodium Hydroxide, Diazolidinyl Uréa, Methylparaben, Propylparaben, Disodium EDTA. Gel composition: Water-based gel with polymers. Sachet: PET/Pet-metalized/PE film Thermo-sealed pouch: • Cellulose paper, medical grade Transparent PA/PP film This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are no

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GC-15/E Sterile ultrasound transmission gel-2

TECHNICAL DATA SHEET Physico-chemical properties • Colour, Odour, Appearance: Colourless or slightly yellowish, transparent and viscous gel. Odour to its raw materials (it does not contain perfume). Microbiological properties • Sterile according the normative EN 556-1 standard Conclusion: The product is biocompatible. Sterilization and expiry date • Sterile product by radiation. Shelf life: 2 years upon manufacturing date. Keep protected from direct sunlight / the outside. Single use product. No maintenance required. Double packaging, monodose, 20 ml, 48 unit service box. Apply over the selected...

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GC-15/E Sterile ultrasound transmission gel-3

TECHNICAL DATA SHEET Regulatory information TELIC, S.A.U. guarantees that this product is in conformity with Regulation (UE) 217/745 and that it has been manufactured following the directives of the Quality Assurance System certified as ISO 13485. This product is classified as: • Class I sterile product according to Annex XI of Regulation (UE) 2017/745, rule 1. GMDN code: 58735 – Coupling gel, sterile. EMDN code: Z11040185 (Ultrasound scanners-consumables) This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allowed 3-3

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