Duns Number:825244135
Catalog Number
-
Brand Name
SurgiMesh
Version/Model Number
T1415
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
K061445,K061445
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
039e8b15-03bb-40ef-8f28-5d68cbda5201
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
January 30, 2020
Package DI Number
10850011929152
Quantity per Package
5
Contains DI Package
00850011929155
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 12 |