Catalog Number

VYAA21G7

Brand Name

VYGON

Version/Model Number

VYAA21G7

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

K082580,K082580

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

9a181d4e-e895-4c31-9ed8-c415c791062d

Public Version Date

April 16, 2019

Public Version Number

1

DI Record Publish Date

April 08, 2019

Package DI Number

38498840011769

Quantity per Package

10

Contains DI Package

08498840011768

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-