Identity
- Trade Name
- Wound GelHA Matrix FDA UDI
- Generic Name
- Skin osmotic dressing, non-antimicrobial FDA UDI
- Device Name
- "WoundGelHA MatrixTM is formulated to provide wound care dressing and management. WoundGelHA MatrixTM is a combination of emollients and sodium hyaluronate which function to maintain tissue hydration and support the healing process. WoundGelHA MatrixTM has been demonstrated to be of value in the management of certain skin ulcers. Sodium hyaluronate is a salt of hyaluronic acid, a naturally occurring molecule found in various body tissues. The sodium hyaluronate present in WoundGelHA MatrixTM is derived from synthetic sources. " FDA UDI
- Model / Reference
- Three - 1/3 oz. Tubes FDA UDI
- Description
- "WoundGelHA MatrixTM is formulated to provide wound care dressing and management. WoundGelHA MatrixTM is a combination of emollients and sodium hyaluronate which function to maintain tissue hydration and support the healing process. WoundGelHA MatrixTM has been demonstrated to be of value in the management of certain skin ulcers. Sodium hyaluronate is a salt of hyaluronic acid, a naturally occurring molecule found in various body tissues. The sodium hyaluronate present in WoundGelHA MatrixTM is derived from synthetic sources. " FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00358407992535 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Skin osmotic dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Skin osmotic dressing, non-antimicrobial
Wound GelHA Matrix by Industria Farmacéutica Andrómaco, S.A. de C.V. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin osmotic dressing, non-antimicrobial.
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
- Industria Farmacéutica Andrómaco, S.A. de C.V.
Sources (1)
- FDA UDI cf474463-d3b4-4405-a6b4-fcbaf4f50054 33 fields · synced Jun 8, 2026