Duns Number:117061618
Catalog Number
-
Brand Name
Durasorb Monofilament Mesh
Version/Model Number
PTM1025
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
K181094
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
b1578134-0431-4fe4-a40d-ef21ce311ca8
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
December 17, 2019
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. | 3 |