Catalog Number

421570

Brand Name

GENTLECATH GLIDE

Version/Model Number

421570

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

KOD

Product Code Name

Catheter, Urological

Public Device Record Key

cbfa6f6a-5597-4588-a06d-c454cdb639b0

Public Version Date

October 27, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

50768455143578

Quantity per Package

30

Contains DI Package

30768455143574

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton