Catalog Number

A399400

Brand Name

SureStep™ Foley Tray System Add-A-Foley Catheter

Version/Model Number

A399400

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

Yes

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

-

FDA Premarket Submission

-

Product Code

KNX

Product Code Name

COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Public Device Record Key

025d85d4-6bfd-4c60-b968-7cc1e41af308

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

December 08, 2015

Package DI Number

10801741100366

Quantity per Package

10

Contains DI Package

00801741100369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA