Identity
- Trade Name
- Provox Skin Barrier (50 pcs) EUDAMEDFDA UDI
- Generic Name
- Synthetic-polymer liquid barrier dressing FDA UDI
- Device Name
- Provox Skin Barrier EUDAMEDProvox Skin Barrier is a single use wipe for laryngectomized patients that forms a barrier between Provox Adhesive and the skin. FDA UDI
- Model / Reference
- 8011 EUDAMEDFDA UDI
- Description
- Provox Skin Barrier is a single use wipe for laryngectomized patients that forms a barrier between Provox Adhesive and the skin. FDA UDI
Identifiers
- Catalog Number
- 8011 FDA UDI
- Primary DI / UDI-DI
- 07331791009228 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-ADH-A-000-0004-UL EUDAMED
- Unit of Use DI
- 07331791016363 EUDAMED
- FDA Product Code
- NEC FDA UDI
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
- GMDN Term
- Synthetic-polymer liquid barrier dressing FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5090 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Synthetic-polymer liquid barrier dressing
Provox Skin Barrier (50 pcs) by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Synthetic-polymer liquid barrier dressing.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI 4c0a3df5-65ed-449b-b8b8-47a6a2911382 36 fields · synced Jun 18, 2026
- EUDAMED 98666d66-25eb-45c6-b758-adef1be5b73c 61 fields · synced Jun 18, 2026