Catalog Number

A899100

Brand Name

Sure Step™ Foley Tray System Add-A-Foley

Version/Model Number

A899100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 2022

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

6330d86d-2b78-429c-883b-e541bb1f2b2c

Public Version Date

May 18, 2022

Public Version Number

5

DI Record Publish Date

December 08, 2015

Package DI Number

10801741108799

Quantity per Package

10

Contains DI Package

00801741108792

Package Discontinue Date

September 30, 2021

Package Status

Not in Commercial Distribution

Package Type

CA