Catalog Number

991101

Brand Name

Bard® Renal Sheath

Version/Model Number

991101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K080944,K080944

Product Code

LJE

Product Code Name

CATHETER, NEPHROSTOMY

Public Device Record Key

e496928f-826b-463e-84d6-e72e7dbdd9f9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 10, 2016

Package DI Number

10801741095013

Quantity per Package

5

Contains DI Package

00801741095016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA