Identity
- Trade Name
- Hybrid Dressing FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(10 cm x 30 cm) , UP-D1520(15 cm x 20 cm) , UP-D1530(15 cm x 30 cm), XLR8 Port Pad (XP-1012, XP-1013) and 1 piece transparent film 26 cm x 30 cm cut into 5 pieces is a single patient use, disposable, non-invasive kit designed to be used along with recommended Genadyne NPWT pumps. The kit is intended to be used on moderate to low severity wounds. FDA UDI
- Model / Reference
- UP-D1030 FDA UDI
- Description
- The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(10 cm x 30 cm) , UP-D1520(15 cm x 20 cm) , UP-D1530(15 cm x 30 cm), XLR8 Port Pad (XP-1012, XP-1013) and 1 piece transparent film 26 cm x 30 cm cut into 5 pieces is a single patient use, disposable, non-invasive kit designed to be used along with recommended Genadyne NPWT pumps. The kit is intended to be used on moderate to low severity wounds. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405001638 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
Yes
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
Yes
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 d016e992-7a49-4e89-b497-f2f53adecba9 33 fields · synced Jun 4, 2026