Catalog Number

63614

Brand Name

Personal Catheter™ Intermittent Catheter

Version/Model Number

63614

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"

Yes

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

cc935d16-a535-4baa-a805-a28d7567d37e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 23, 2016

Package DI Number

10801741069298

Quantity per Package

30

Contains DI Package

00801741069291

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA