Identity
- Trade Name
- Hybrid Dressing FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- Hybrid Dressing 10x30 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drapes. The three components are packaged together. FDA UDI
- Model / Reference
- UP-D1030/5 FDA UDI
- Description
- Hybrid Dressing 10x30 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drapes. The three components are packaged together. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405001706 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Hybrid Dressing by Genadyne Biotechnologies, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
Sources (1)
- FDA UDI 452406bb-e320-4b8c-bd7e-8bdb3408fe76 33 fields · synced Jun 4, 2026