Catalog Number

-

Brand Name

Supercath 5

Version/Model Number

SP120-16-31-WT

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)

-

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

K190001,K190001,K190001

Product Code

FOZ

Product Code Name

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

Public Device Record Key

ff51b622-0fb6-4754-a338-1230c223c66c

Public Version Date

March 31, 2022

Public Version Number

4

DI Record Publish Date

April 24, 2018

Package DI Number

14543527241622

Quantity per Package

50

Contains DI Package

04543527241625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box