Duns Number:395941714
Device Description: A non woven, non knitted layer reinforcement material made from polypropylene and a silico A non woven, non knitted layer reinforcement material made from polypropylene and a silicone layer
Catalog Number
TINTRAXM
Brand Name
SURGIMESH®XB
Version/Model Number
TINTRAXM
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
-
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
5f667186-2ff8-4f15-870f-0b81b05d97e3
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
October 23, 2015
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. | 44 |