Sion Biotext Medical Ltd. 54W211-1206-912

GUDID 37290101427804

Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, forms a protective film to help reduce friction during removal of tapes and films. It leaves a thin breathable film on the skin, which protects it against potential damage. It dries within seconds and does not build up residue on the skin, leaving you ready to apply a new barrier. The product's discreet packaging makes it practical for traveling or use on-the-go.

SION BIOTEXT MEDICAL LTD

Skin adhesive protective material

• Primary Device ID: 37290101427804
• NIH Device Record Key: 540d3354-2f90-4659-a44c-8199986fb481
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sion Biotext Medical Ltd.
• Version Model Number: 1
• Catalog Number: 54W211-1206-912
• Company DUNS: 532775194
• Company Name: SION BIOTEXT MEDICAL LTD
• Device Count: 100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290101427803 [Unit of Use]
GS1	37290101427804 [Primary]

FDA Product Code

• NEC: Bandage, Liquid, Skin Protectant

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: 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