Sion Biotext Medical Ltd. 54J506-0109-000

GUDID 07290101428350

The Amorphous Hydrogel product family is intended to maintain a moist environment by donating moisture to dry or minimally exudating wounds. Viscous and non-oily formulation remains in place in the wound bed. The products are non-sterile, intended for multi-use with continuous use of up to 30 days. Not made with natural rubber latex | Non-cytotoxic | Non-irritating

SION BIOTEXT MEDICAL LTD

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 07290101428350
• NIH Device Record Key: d42a67b6-c8be-439e-a1df-422c359ad458
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sion Biotext Medical Ltd.
• Version Model Number: 1
• Catalog Number: 54J506-0109-000
• Company DUNS: 532775194
• Company Name: SION BIOTEXT MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290101428350 [Primary]

FDA Product Code

• NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-02
• Device Publish Date: 2025-08-25

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
• 17290100663308: The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-ir
• 17290100666156: The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-ir
• 07290100665640: Gauze impregnated with a paste containing Zinc Oxide and Calamine. Ideal for conditions that req
• 07290100665633: Gauze impregnated with a paste containing Zinc Oxide and Calamine. Ideal for conditions that req
• 07290100665626: Gauze impregnated with a paste containing Zinc Oxide and Glycerine. Ideal for conditions that re
• 07290100665619: Gauze impregnated with a paste containing Zinc Oxide and Glycerine. Ideal for conditions that re
• 72901014283670: The Amorphous Hydrogel product family is intended to maintain a moist environment by donating mo
• 07290101428350: The Amorphous Hydrogel product family is intended to maintain a moist environment by donating mo