Identity
- Trade Name
- Wittmann Patch FDA UDI
- Generic Name
- Negative-pressure wound therapy open-abdomen dressing FDA UDI
- Device Name
- For temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. FDA UDI
- Model / Reference
- EWP2040 FDA UDI
- Description
- For temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810805000187 FDA UDI
- 510(k) Number
- K983753 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Negative-pressure wound therapy open-abdomen dressing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
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: Negative-pressure wound therapy open-abdomen dressing
Wittmann Patch by Preservation Solutions, 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
- Preservation Solutions, Inc.
Sources (1)
- FDA UDI f9bf4a75-3e97-4cea-b493-2895c8d65b78 35 fields · synced May 29, 2026