Catalog Number

VYG45MN-R

Brand Name

VYGON

Version/Model Number

VYG45MN-R

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K021990,K021990

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

10c36a01-77a5-4fb7-be97-05e36f31e925

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

January 27, 2020

Package DI Number

30849884004343

Quantity per Package

20

Contains DI Package

00849884004342

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-