Home GUDID 17290100666156
Sion Biotext Medical Ltd.
Primary DI 17290100666156
Brand Sion Biotext Medical Ltd.
Company SION BIOTEXT MEDICAL LTD
Model 1
Catalog number 53J805-3011-000
Device description The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-irritating lubricant. It is water soluble, high viscosity gel-like liquid for use as a lubricating media for insertion of medical instruments during medical procedures. It is easily rinsed off with water. The Lubricating Jelly is designed for medical purposes to lubricate body orifices, assisting in the insertion of devices for diagnostic and therapeutic purposes. It is a water-soluble jelly that spreads easily to form a translucent film and is easily washed away. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The product is packaged in a convenient plastic dispenser, laminate tube with a flip top cap, in an aluminum foil/plastic laminate sachet or syringe. The lubricant is sterilized using gamma radiation.
Published 2025-04-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true
Product Codes# Code, Name table Code Name KMJ Lubricant, Patient
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KMJ Lubricant, Patient General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17290100666156 Primary GS1 0 07290100666159 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17290100666156 17290100666156 07290100666159 07290100666159 7290100666159
GMDN Terms# Term, Definition table Term Definition General-body orifice lubricant A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 532775194 Device count 144 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290101428350 Sion Biotext Medical Ltd. 1 54J506-0109-000 2025-08-25 72901014283670 Sion Biotext Medical Ltd. 1 54J506-0309-000 2025-08-25 07290100665619 Sion Biotext Medical Ltd. 1 54C156-1090-000 2025-07-08 07290100665626 Sion Biotext Medical Ltd. 1 54C156-7590-000 2025-07-08 07290100665633 Sion Biotext Medical Ltd. 1 54C257-1090-000 2025-07-08 07290100665640 Sion Biotext Medical Ltd. 1 54C257-7590-000 2025-07-08 17290100663308 Sion Biotext Medical Ltd. 1 53J805-5001-000 2023-09-19 07290100663288 Sion Biotext Medical Ltd. 1 53J505-1009-000A 2023-09-19 07290100663301 Sion Biotext Medical Ltd. 1 53J805-5001-000A 2023-09-19 17290101427800 Sion Biotext Medical Ltd. 1 54W211-1205-912 2023-09-19 17290101427817 Sion Biotext Medical Ltd. 1 54W209-1205-912 2023-09-19 37290101427804 Sion Biotext Medical Ltd. 1 54W211-1206-912 2023-09-19 37290101427811 Sion Biotext Medical Ltd. 1 54W209-1206-912 2023-09-19
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