Catalog Number

INTL16

Brand Name

SureStep Intermittent Catheter Tray

Version/Model Number

INTL16

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

aa565c68-fa88-40a0-a902-08a8b40e433e

Public Version Date

November 21, 2019

Public Version Number

1

DI Record Publish Date

November 13, 2019

Package DI Number

10801741183185

Quantity per Package

20

Contains DI Package

00801741183188

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA