Catalog Number

4196505

Brand Name

URI-CATH

Version/Model Number

Silicone Catheter

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K941672,K941672

Product Code

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

8d1faaab-ba29-4e9f-9f27-a0205e6dafc0

Public Version Date

June 02, 2022

Public Version Number

1

DI Record Publish Date

May 25, 2022

Package DI Number

H67141965051

Quantity per Package

10

Contains DI Package

H67141965050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box