Catalog Number

508992

Brand Name

GentleCathTM

Version/Model Number

508992

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"

-

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

EZD

Product Code Name

CATHETER, STRAIGHT

Public Device Record Key

9963e7b2-4bdb-4ce8-bf9d-2bdfaf141dfe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

00768455136087

Quantity per Package

30

Contains DI Package

00768455142606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-