Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-F614

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

K142767,K142767,K142767

Product Code

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

3b70235d-48ed-40bb-ac00-8072de05e31c

Public Version Date

December 04, 2020

Public Version Number

9

DI Record Publish Date

December 09, 2016

Package DI Number

20612479213788

Quantity per Package

30

Contains DI Package

10612479213774

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box