Catalog Number

-

Brand Name

CATH-SECURE PLUS with Skin Barrier Wipe

Version/Model Number

54456P

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EYJ

Product Code Name

Holder, Ureteral Catheter

Public Device Record Key

d9195ca4-7e54-4836-84f9-a00d70d09bc3

Public Version Date

January 14, 2021

Public Version Number

1

DI Record Publish Date

January 06, 2021

Package DI Number

10048329000025

Quantity per Package

40

Contains DI Package

00048329000028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER CARTON