Kumar Catheter® - The Kumar Catheter®, used in conjunction with - NASHVILLE SURGICAL INSTRUMENTS, LLC

Duns Number:030096122

Device Description: The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to pr The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises a translucent tubing ( 76 cm. length and 16 ga. ) that carries a 19 ga., 1.25 cm long needle at the end. The Kumar Catheter® is used to puncture the Hartmann's pouch of the gallbladder for biliary access and / or aspiration. Product is latex free.

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More Product Details

Catalog Number

CC-019

Brand Name

Kumar Catheter®

Version/Model Number

CC019

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K973621,K973621

Product Code Details

Product Code

GBZ

Product Code Name

Catheter, Cholangiography

Device Record Status

Public Device Record Key

b243bd66-2330-4f16-ad1a-0f037f481d94

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 15, 2017

Additional Identifiers

Package DI Number

B361CC0191

Quantity per Package

20

Contains DI Package

B361CC0190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"NASHVILLE SURGICAL INSTRUMENTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2