Duns Number:576342646
Device Description: Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
Catalog Number
-
Brand Name
Parietene DS
Version/Model Number
PPDS1510X3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K163212,K163212
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
8ed205e4-f436-4f5a-a3e2-5d9dbed10073
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
December 15, 2017
Package DI Number
20884521553535
Quantity per Package
3
Contains DI Package
10884521553538
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 239 |