Identity
- Trade Name
- H&H FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- "H&H" Wound Gel (Sterile) is a transparent gel dressing with an amorphous structure, suitable for irregularly shaped wounds. The formulation is designed to achieve isotonicity, allowing the gel to cover the wound bed, providing a moist wound healing environment, and promoting the migration of new epidermal cells. Carboxymethyl cellulose, combined with glycerol and hyaluronic acid, not only helps absorb wound exudate and blood but also forms a moist gel protective layer on the wound bed, providing an optimal moist healing environment while reducing the risk of infection by acting as a barrier to foreign materials. FDA UDI
- Model / Reference
- WG0030 FDA UDI
- Description
- "H&H" Wound Gel (Sterile) is a transparent gel dressing with an amorphous structure, suitable for irregularly shaped wounds. The formulation is designed to achieve isotonicity, allowing the gel to cover the wound bed, providing a moist wound healing environment, and promoting the migration of new epidermal cells. Carboxymethyl cellulose, combined with glycerol and hyaluronic acid, not only helps absorb wound exudate and blood but also forms a moist gel protective layer on the wound bed, providing an optimal moist healing environment while reducing the risk of infection by acting as a barrier to foreign materials. FDA UDI
Identifiers
- Catalog Number
- WG0030 FDA UDI
- Primary DI / UDI-DI
- 04719884331402 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 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
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
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 30 Milliliter FDA UDI
Category: Wound hydrogel dressing, non-antimicrobial
H&H by Tronjen Medical Technology 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
- Tronjen Medical Technology Inc.
Sources (1)
- FDA UDI 0c63b2b1-610d-4ce3-853d-92c1bd2db2f6 35 fields · synced May 30, 2026