Identity
- Trade Name
- Wound GelHA TM FDA UDI
- Generic Name
- Skin osmotic dressing, non-antimicrobial FDA UDI
- Device Name
- WoundGelHA TM is indicated for the management of minor burns, abrasions, & cuts and helps relieve dry waxy skinassociated with dry skin conditions. FDA UDI
- Model / Reference
- One, 0.33 oz (9.45g) Tube FDA UDI
- Description
- WoundGelHA TM is indicated for the management of minor burns, abrasions, & cuts and helps relieve dry waxy skinassociated with dry skin conditions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00358407070011 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 TM 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 f230db6c-f9aa-41ed-80db-92e92b4e9455 33 fields · synced May 30, 2026