AccessGUDID - DEVICE: Kumar T-ANCHORS® Hernia Set (B361TA0080)

GUDID

Device Identifier (DI) Information

Brand Name: Kumar T-ANCHORS® Hernia Set
Version or Model: TA-008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TA-008
Company Name: NASHVILLE SURGICAL INSTRUMENTS, LLC

Primary DI Number: B361TA0080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030096122 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62844	Surgical mesh T fastener	An implantable device intended to be inserted percutaneously across the abdominal wall for trans-fascial fixation of a surgical mesh in the treatment of abdominal hernia. It consists of a metal T-bar with an attached non-bioabsorbable polymer suture, and includes appropriate introduction devices (e.g., needle, pusher stylet).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GDW	Staple, Implantable
GAR	Suture, Nonabsorbable, Synthetic, Polyamide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081366	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 45 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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