Sion Biotext Medical Ltd. 53J505-1009-000A

GUDID 07290100663288

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.

SION BIOTEXT MEDICAL LTD

General-body orifice lubricant

• Primary Device ID: 07290100663288
• NIH Device Record Key: 8b8481f2-ee82-4c7a-ab7e-3ca85eb9c80c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sion Biotext Medical Ltd.
• Version Model Number: 1
• Catalog Number: 53J505-1009-000A
• Company DUNS: 532775194
• Company Name: SION BIOTEXT MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com
• Phone: +97286898650
• Email: customer-service@sn-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290100663288 [Primary]

FDA Product Code

• KMJ: Lubricant, Patient

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

[07290100663288]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-27
• Device Publish Date: 2023-09-19

On-Brand Devices [Sion Biotext Medical Ltd.]

• 37290101427811: Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical ad
• 37290101427804: Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, form
• 17290101427817: Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical ad
• 17290101427800: Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, form
• 07290100663301: The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-ir
• 07290100663288: The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-ir