Catalog Number

509009

Brand Name

GentleCathTM

Version/Model Number

509009

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

19a9de88-4ce6-46e0-bac7-e861347ee8b1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

10768455136251

Quantity per Package

4

Contains DI Package

00768455136254

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-