Catalog Number

UROET18

Brand Name

URO Saf-Gard Extension Tubing

Version/Model Number

18 inch

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

-

Product Code

KNX

Product Code Name

Collector, Urine, (And Accessories) For Indwelling Catheter

Public Device Record Key

86582283-a03e-499d-81e8-ee9a4d7ddaeb

Public Version Date

August 12, 2019

Public Version Number

1

DI Record Publish Date

August 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-