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Telic Group
Lubricating water soluble gel

Lubricating water soluble gel

Product catalog summary

Product Description:
DORMO is a lubricating water-soluble gel suitable for hospital and nursing processes requiring non-specific lubrication. It is easy to clean, non-irritating, and does not damage equipment or materials such as plastic, metal, textile, and rubber.

Technical Specifications:

Composition: Aqua, Glycerin, Propylene Glycol, Hydroxyethyl Cellulose, Polyquaternium-7, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA, Sodium Benzoate.
Physico-chemical properties: Yellowish transparent viscous gel with a viscosity of >200,000—400,000 cps, pH of 5.5 – 6.5, and density of 1.01 – 1.03 g/ml.
Materials: Coex tube PEBD-EVOH-PEBD, PP cap with plastiband, printed cardboard box.

Microbiological Properties:

Total aerobes: <10 ufc/ml
Moulds and yeasts: <10 ufc/ml
Pathogens: Absence of Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, Escherichia coli.

Biocompatibility:

ISO 10993-5: No cytotoxic
ISO 10993-10: No sensitizing and negative intracutaneous irritation test
Conclusion: The product is biocompatible.

Sterilization and Expiry Date:

Non-sterile product.
Shelf life: 3 years from the manufacturing date.

Instructions for Use:

Apply to the selected area or instruments, spreading the gel evenly.
Perform the medical procedure according to usual protocols.
Remove remaining product with a disposable wipe when appropriate.

Storage and Maintenance:

Keep protected from direct sunlight and in a dry place.
Single-use product with no maintenance required.

Regulatory Information:

Conforms with Regulation (UE) 2017/745 and ISO 13485.
Class I product according to Rule 5 of Annex VIII of Regulation (UE) 2017/745.
GMDN code: 33587 General-body orifice lubricant, non-sterile.
EMDN code: M9002 (Protective sprays and lubricant sprays gels, fluids, and creams).

Packaging:

100ml tube in a unitary case, 24 cases per service box.

Catalog excerpts

TECHNICAL DATA SHEET Lubricating water soluble gel DORMO Product description Lubricating water-soluble gel, adequate for hospital and nursing proceses that require non-specific lubrication. Product charasteristics • Hospital and nursing processes where non-specific lubrication is required. Does not damage equipment, nor plastic, metal, textile, rubber materials. Technical specifications Composition (INCI) Aqua (Water), Glycerin, Propylene Glycol, Hidroxyethyl Cellulose, Polyquaternium-7, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA, Sodium Benzoate. Materials • Coex tube PEBD-EVOH-PEBD. Physico-chemical properties • Colour, odour, appearance: yellowish transparent viscous gel, slippery, odour to its raw materials (it does not contain perfume). This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are n

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TECHNICAL DATA SHEET Microbiological properties • Pathogens (Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, Escherichia coli): Absence ISO 10993-10: negative intracutaneous irritation test Conclusion: the product is biocompatible. Sterilization and expiry date • Non-sterile product. Shelf life: 3 years upon the manufacturing date. Keep protected from direct sunlight / the outside. Single use product. No maintenance required. 100ml tube in an unitary case. 24 cases per service box. 1. Apply to the selected area or instruments, spreading the gel evenly. Perform the medical procedure...

Open the catalog to page 2

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