Duns Number:344675942
Device Description: Ti-Mesh 1.4" X 4" Light 35g/m²
Catalog Number
-
Brand Name
TiMESH
Version/Model Number
6000737
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2021
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
7cc59412-1a12-4a9d-82d1-898029719c6b
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
December 09, 2019
Package DI Number
04042301144324
Quantity per Package
3
Contains DI Package
04042301144317
Package Discontinue Date
November 01, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 12 |