Duns Number:090266979
Device Description: For temporary bridging of abdominal wall openings where primary closure is not possible an For temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary.
Catalog Number
-
Brand Name
Wittmann Patch
Version/Model Number
EWP2040
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983753
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
f9bf4a75-3e97-4cea-b493-2895c8d65b78
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |