Catalog Number

INTL16C

Brand Name

SureStep Intermittent Catheter Tray

Version/Model Number

INTL16C

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

EZC

Product Code Name

CATHETER, COUDE

Public Device Record Key

a9e01ce4-f971-4082-a6ed-407f3e19dab1

Public Version Date

November 21, 2019

Public Version Number

1

DI Record Publish Date

November 13, 2019

Package DI Number

10801741183192

Quantity per Package

20

Contains DI Package

00801741183195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA