Catalog Number

-

Brand Name

Supercath 5

Version/Model Number

SP201-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 11, 2018

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140419,K140419,K140419

Product Code

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Public Device Record Key

701007aa-d59d-4047-aca6-af0fe77d314f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

74543527235371

Quantity per Package

20

Contains DI Package

14543527235379

Package Discontinue Date

November 11, 2016

Package Status

Not in Commercial Distribution

Package Type

Carton