Duns Number:341661031
Device Description: Hernia Mesh made of 100% Polyvinylidene Fluorid
Catalog Number
PV230506F1
Brand Name
DynaMesh
Version/Model Number
VENTRAL
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
-
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
e7e7b26e-04d9-47e6-ba4e-16d5f8ad84a3
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
May 07, 2017
Package DI Number
04250274705613
Quantity per Package
5
Contains DI Package
04250274705606
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 |