Identity
- Trade Name
- Sion Biotext Medical Ltd. FDA UDI
- Generic Name
- Skin adhesive protective material FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 54W211-1206-912 FDA UDI
- Primary DI / UDI-DI
- 37290101427804 FDA UDI
- FDA Product Code
- NEC FDA UDI
- GMDN Term
- Skin adhesive protective material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5090 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Skin adhesive protective material
Sion Biotext Medical Ltd. by Sion Biotext Medical Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin adhesive protective material.
- Vitus — H R Pharmaceuticals, Inc. · Class I
- DropSafe™ Inject-Safe Barrier Bandage™ — HTL STREFA S A · Class I
- LERNA — Lernapharm (Loris) Inc · Class I
- Sion Biotext Medical Ltd. — SION BIOTEXT MEDICAL LTD · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sion Biotext Medical Ltd
Sources (1)
- FDA UDI 540d3354-2f90-4659-a44c-8199986fb481 34 fields · synced Jun 8, 2026