Sion Biotext Medical Ltd. 54W209-1205-912

GUDID 17290101427817

Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical adhesive products.

SION BIOTEXT MEDICAL LTD

Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover Patient medical adhesive remover

• Primary Device ID: 17290101427817
• NIH Device Record Key: 4df1f7e6-70c7-4b7e-8fbc-065948478294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sion Biotext Medical Ltd.
• Version Model Number: 1
• Catalog Number: 54W209-1205-912
• 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	07290101427810 [Unit of Use]
GS1	17290101427817 [Primary]

FDA Product Code

• KOY: Degreaser, Skin, Surgical

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