Catalog Number

-

Brand Name

CATH-SECURE

Version/Model Number

5445-3

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)

-

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

c7a7f664-8c68-4d81-8fae-da3b598f60be

Public Version Date

October 23, 2019

Public Version Number

1

DI Record Publish Date

October 15, 2019

Package DI Number

20048329000244

Quantity per Package

8

Contains DI Package

10048329000247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER SHIP CASE