Duns Number:002144145
Device Description: Undyed Knitted (Polyglactin 910), Synthetic Absorbable Mesh
Catalog Number
VKMM
Brand Name
VICRYL
Version/Model Number
VKMM
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
K810428,K810428
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
df310950-9a99-47c3-b5c1-04dd444f1058
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
20705031056920
Quantity per Package
3
Contains DI Package
10705031056923
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |