Identity
- Trade Name
- Provox Life Sensitive Adhesive Oval FDA UDI
- Generic Name
- Removable ambulatory appliance skin-adherent patch FDA UDI
- Device Name
- Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy. Provox Life Sensitive Adhesives have an adhesive material with permanent skin contact that is hypoallergenic and suitable for sensitive skin. FDA UDI
- Model / Reference
- 7464 FDA UDI
- Description
- Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy. Provox Life Sensitive Adhesives have an adhesive material with permanent skin contact that is hypoallergenic and suitable for sensitive skin. FDA UDI
Identifiers
- Catalog Number
- 7464 FDA UDI
- Primary DI / UDI-DI
- 07331791014468 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Removable ambulatory appliance skin-adherent patch FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 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
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: Removable ambulatory appliance skin-adherent patch
Provox Life Sensitive Adhesive Oval by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Atos Medical Inc.
Sources (1)
- FDA UDI 3b09b340-1b1f-41ac-ad8d-a82b885cd89f 36 fields · synced May 30, 2026