Catalog Number

-

Brand Name

UroPass Ureteral Access Sheath

Version/Model Number

61254BX

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"

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

K051593,K051593

Product Code

KNY

Product Code Name

ACCESSORIES, CATHETER, G-U

Public Device Record Key

8e510cc3-dce6-4620-af34-dfb925c5f1ca

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

October 12, 2016

Package DI Number

00821925005990

Quantity per Package

5

Contains DI Package

00821925035423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-