Duns Number:459310140
Device Description: Plug T4 is a rigid pre-shaped mesh with eccentric hole knitted with Polypropylene monofila Plug T4 is a rigid pre-shaped mesh with eccentric hole knitted with Polypropylene monofilament, indicated in medium-large in direct inguinal hernias, to reduce the size of an enlarged internal ring and also reinforces the surrounding tissues.
Catalog Number
-
Brand Name
PLUG T4
Version/Model Number
PT4R-R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 11, 2019
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
83cf02fd-52d1-49fe-a518-b6f00332084b
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
January 08, 2018
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. | 14 |