Catalog Number

A322418A

Brand Name

SureStep™ Foley Tray System Lubri-Sil® I.C. Complete Care® Foley Catheter

Version/Model Number

A322418A

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

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Public Device Record Key

aeeee28f-2e52-4467-9b5f-246cc4dc3c69

Public Version Date

May 18, 2022

Public Version Number

4

DI Record Publish Date

July 12, 2016

Package DI Number

10801741100656

Quantity per Package

10

Contains DI Package

00801741100659

Package Discontinue Date

January 28, 2022

Package Status

Not in Commercial Distribution

Package Type

CA