Duns Number:080524654
Catalog Number
-
Brand Name
Ventral Wall Defect Silo Bag
Version/Model Number
GR74089-02
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
K840172
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
1dc17b5c-a3d0-4a3e-a5d4-e5d756989312
Public Version Date
May 10, 2019
Public Version Number
4
DI Record Publish Date
January 03, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 92 |