Catalog Number

-

Brand Name

GENTLECATH

Version/Model Number

421910

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

K181206,K181206,K181206

Product Code

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

93366310-5fd6-4b3c-b9d8-41f43e8329fe

Public Version Date

October 14, 2022

Public Version Number

6

DI Record Publish Date

February 22, 2019

Package DI Number

70768455153823

Quantity per Package

8

Contains DI Package

50768455153829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case