AccessGUDID - DEVICE: Kumar Clamp® (B361KC0020)

GUDID

Device Identifier (DI) Information

Brand Name: Kumar Clamp®
Version or Model: KC-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KC-002
Company Name: NASHVILLE SURGICAL INSTRUMENTS, LLC

Primary DI Number: B361KC0020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030096122 *Terms of Use

Device Description: The Kumar Clamp® is a reusable 5mm stainless steel laparoscopic grasper of 37 cm length with long ( 3.8 cm) atraumatic jaws and a channel for introduction of the single use Kumar Catheter®. The system is meant to provide a method of laparoscopic cholangiography.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
62667	Laparoscopic tissue manipulation forceps/working-channel	A rigid, hand-held manual surgical instrument designed to be introduced through a laparoscope/laparoscopic port for: 1) atraumatic grasping/clamping of soft tissues (e.g., gallbladder); and 2) access adjacent to the site of clamping (e.g., during laparoscopic cholangiography). It is a hand-held device with proximal handles, a rigid long slender shaft with a built-in working-channel, and distal grasping blades. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBZ	Catheter, Cholangiography

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973621	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Millimeter
Length: 37 Centimeter

Device Record Status

Public Device Record Key: 904e21e2-5e41-40c9-9cd6-ab719b633a68
Public Version Date: August 21, 2019
Public Version Number: 4
DI Record Publish Date: August 15, 2017