Catalog Number

421425

Brand Name

GENTLECATH

Version/Model Number

421425

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2022

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"

-

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

K010420

Product Code

FCM

Product Code Name

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Public Device Record Key

5897a3c7-dbaf-4336-b220-458a982642bb

Public Version Date

May 23, 2022

Public Version Number

10

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-