Duns Number:030096122
Device Description: The Kumar T-ANCHORS® Hernia Set provides a means of Fixation of the Mesh in Laparoscopic o The Kumar T-ANCHORS® Hernia Set provides a means of Fixation of the Mesh in Laparoscopic or Open Repair of Abdominal Wall Hernia as Trans-fascial sutures, in addition to the tackers. Kumar T-ANCHORS® eliminate the need for grasping and feeding of sutures into a Suture Passer.
Catalog Number
TA-008
Brand Name
Kumar T-ANCHORS® Hernia Set
Version/Model Number
TA-008
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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"
Yes
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
K081366,K081366
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
249d5644-0438-4f20-939f-208e885bbe8c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 15, 2017
Package DI Number
B361TA0081
Quantity per Package
10
Contains DI Package
B361TA0080
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |