Identity
- Trade Name
- Provox Silicone Glue EUDAMEDFDA UDI
- Generic Name
- Synthetic-polymer liquid barrier dressing FDA UDI
- Device Name
- Provox Silicone Glue EUDAMEDProvox Silicone Glue is a liquid glue used for increased adhesion of the Provox Adhesive. The glue cures via air contact. Long-term use may cause skin irritation. FDA UDI
- Model / Reference
- 7720 EUDAMEDFDA UDI
- Description
- Provox Silicone Glue is a liquid glue used for increased adhesion of the Provox Adhesive. The glue cures via air contact. Long-term use may cause skin irritation. FDA UDI
Identifiers
- Catalog Number
- 7720 FDA UDI
- Primary DI / UDI-DI
- 07331791002984 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-GEN-A-000-0003-EF EUDAMED
- FDA Product Code
- GBJ 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
- 878.3750 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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 Silicone Glue 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 afc1ad01-f0b9-4e16-b51b-5b08b2baa1d7 36 fields · synced Jul 15, 2026
- EUDAMED a583d6a4-68e2-4bbc-a2a5-ddc6b4aef06d 61 fields · synced Jul 15, 2026