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Wittmann Patch

FDA UDI

Class II (US FDA UDI)

by Preservation Solutions, Inc.

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

Similar devices

Also classified as Negative-pressure wound therapy open-abdomen dressing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI f9bf4a75-3e97-4cea-b493-2895c8d65b78 35 fields · synced May 29, 2026