H&H
- Primary DI
- 04719884331402
- Brand
- H&H
- Company
- TRONJEN MEDICAL TECHNOLOGY INC.
- Model
- WG0030
- Catalog number
- WG0030
- Device 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.
- Published
- 2023-07-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04719884331426 | Package | GS1 | 16 | In Commercial Distribution |
| 04719884331402 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04719884331426 | 04719884331426 | 4719884331426 |
| 04719884331402 | 04719884331402 | 4719884331402 |
GMDN Terms
| Term | Definition |
|---|---|
| Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Total Volume | 30 | Milliliter |
Sterilization Methods
| Method |
|---|
| Radiation Sterilization |
Regulatory Flags
- DUNS number
- 657496877
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04719884330269 | H&H | SC2106 | 2025-12-12 | |
| 04719884330368 | H&H | SC2106 | 2025-12-12 | |
| 04719884333765 | H&H | SG0007 | 2025-12-11 | |
| 04719884330139 | H&H | HW2106 | HW2106 | 2023-07-20 |
| 04719884330146 | H&H | HW1206 | HW1206 | 2023-07-20 |
| 04719884330153 | H&H | HW0505 | HW0505 | 2023-07-20 |
| 04719884330214 | H&H | SH1206 | SH1206 | 2023-07-20 |
| 04719884330221 | H&H | SH0505 | SH0505 | 2023-07-20 |
| 04719884330207 | H&H | SH2106 | SH2106 | 2023-07-20 |
| 04719859641932 | H&H | HW2106 | HW2106 | 2020-06-12 |
| 04719859641949 | H&H | HW1206 | HW1206 | 2020-06-12 |
| 04719859641956 | H&H | HW0505 | HW0505 | 2020-06-12 |
| 04719859642014 | H&H | SH1206 | SH1206 | 2020-06-12 |
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| 04719859642007 | H&H | SH2106 | SH2106 | 2020-06-12 |
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