Duns Number:277619636
Device Description: Polyester mesh coated with collagen membrane
Catalog Number
CVM12RUS
Brand Name
COVAMESH
Version/Model Number
MSH 08 D12 V
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 2016
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
a8edb181-9a3b-48d3-9d93-7f406ab728d8
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
February 25, 2016
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. | 22 |