Catalog Number

1212.04

Brand Name

VYGON

Version/Model Number

1212.04

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

-

Product Code

FOZ

Product Code Name

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

Public Device Record Key

6c078985-daf9-47de-a2d5-aa4e5740cdbc

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

March 30, 2018

Package DI Number

33660812011298

Quantity per Package

20

Contains DI Package

03660812011297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box