Identity
- Trade Name
- PowerHeal Kit FDA UDI
- Generic Name
- Bioelectric wound dressing FDA UDI
- Device Name
- PowerHeal Kit, 4"x4" 3-layer clear adhesive & Energel FDA UDI
- Model / Reference
- 4"x4" 3-layer and Energel FDA UDI
- Description
- PowerHeal Kit, 4"x4" 3-layer clear adhesive & Energel FDA UDI
Identifiers
- Catalog Number
- PFK-4040-04 FDA UDI
- Primary DI / UDI-DI
- 00810198031447 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Bioelectric wound dressing 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
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: Bioelectric wound dressing
PowerHeal Kit by Vomaris Wound Care, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioelectric wound dressing.
- Arthrex® — Arthrex, Inc. · U
- Arthrex® — Arthrex, Inc. · U
- Arthrex® — Arthrex, Inc. · U
- Arthrex® — Arthrex, Inc. · U
- Arthrex® — Arthrex, Inc. · U
- Arthrex® — Arthrex, Inc. · U
- Arthrex® — Arthrex, Inc. · U
- Arthrex® — Arthrex, Inc. · U
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
- Vomaris Wound Care, Inc.
Sources (1)
- FDA UDI 377faa21-39b8-4f67-ac1c-90619f8dea07 35 fields · synced May 29, 2026