Sion Biotext Medical Ltd. 54W211-1205-912

GUDID 17290101427800

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 Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material

• Primary Device ID: 17290101427800
• NIH Device Record Key: 9abf5f69-1b1c-4277-9e39-645ed85fd000
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sion Biotext Medical Ltd.
• Version Model Number: 1
• Catalog Number: 54W211-1205-912
• Company DUNS: 532775194
• Company Name: SION BIOTEXT MEDICAL LTD
• Device Count: 50
• 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	17290101427800 [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