Duns Number:341661031
Device Description: Hernia Mesh made of 100% Polypropylene
Catalog Number
PP010715F1
Brand Name
DynaMesh
Version/Model Number
PP light 0715
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
dfab18af-1ec4-49db-9bcf-61ef61f46922
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
December 23, 2015
Package DI Number
04250274700311
Quantity per Package
5
Contains DI Package
04250274701547
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 42 |