Duns Number:937305795
Device Description: MAG1-2020: 20cm x 20cm (8in x 8in) MeshHernia MeshPolyvinylidene fluoride/Polybutylene adi MAG1-2020: 20cm x 20cm (8in x 8in) MeshHernia MeshPolyvinylidene fluoride/Polybutylene adipate
Catalog Number
MAG1-2020
Brand Name
InoMesh
Version/Model Number
MAG1-2020
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
7b516c3c-f8e9-4a84-a5ce-28bb55a3c1e8
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
December 28, 2015
Package DI Number
MDLXMAG120203
Quantity per Package
12
Contains DI Package
MDLXMAG120200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-