Identity
- Trade Name
- Prevahex FDA UDI
- Generic Name
- Antimicrobial synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- Prevahex Antimicrobial Transparent Film Dressing FDA UDI
- Model / Reference
- 1483CH FDA UDI
- Description
- Prevahex Antimicrobial Transparent Film Dressing FDA UDI
Identifiers
- Catalog Number
- 1483CH FDA UDI
- Primary DI / UDI-DI
- B5591483CH00 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Antimicrobial synthetic polymer semi-permeable film dressing, adhesive FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex by Entrotech Life Sciences, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Antimicrobial synthetic polymer semi-permeable film dressing, adhesive.
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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 U | Pending data |
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Manufacturer
- Manufacturer
- Entrotech Life Sciences, Llc
Sources (1)
- FDA UDI 0fe805ab-4c76-469a-a32e-2fb3ddb4bec6 34 fields · synced May 30, 2026