Catalog Number

896.038

Brand Name

VYGON

Version/Model Number

896.038

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

e02f573e-006d-4bdc-ac3e-d6ab12819d05

Public Version Date

May 19, 2020

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

53660812061891

Quantity per Package

48

Contains DI Package

33660812061897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-