Identity
- Trade Name
- Provox Wipes EUDAMEDFDA UDI
- Generic Name
- Synthetic-polymer liquid barrier dressing FDA UDI
- Device Name
- Provox Wipes EUDAMEDProvox Skin Barrier is a single use wipe for laryngectomized patients that forms a barrier between Provox Adhesive and the skin.Provox Cleaning Towel is intended for cleaning around the stoma, it will remove oil from the skin. They are indented to use before application of Provox Adhesives. Provox Adhesive Remover is a single use wipe to help laryngectomized patients remove Provox Adhesives and Provox Silicone Glue. FDA UDI
- Model / Reference
- 8243 EUDAMEDFDA UDI
- Description
- Provox Skin Barrier is a single use wipe for laryngectomized patients that forms a barrier between Provox Adhesive and the skin.Provox Cleaning Towel is intended for cleaning around the stoma, it will remove oil from the skin. They are indented to use before application of Provox Adhesives. Provox Adhesive Remover is a single use wipe to help laryngectomized patients remove Provox Adhesives and Provox Silicone Glue. FDA UDI
Identifiers
- Catalog Number
- 8243 FDA UDI
- Primary DI / UDI-DI
- 07331791010392 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-ADH-A-000-0008-UY 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
- Bulgaria 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
Yes
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 Wipes by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 7bd35d23-abe1-4e21-bd23-20b00fd132ba 36 fields · synced Jul 29, 2026
- EUDAMED 7a43ed1b-d8ff-424d-80ce-820e2d51701d 61 fields · synced Jul 29, 2026