Catalog Number

4195005

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

a89cce06-3183-4512-a332-21d2a81e4d77

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

H67141950051

Quantity per Package

10

Contains DI Package

H67141950050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box