Catalog Number

VYAA21G7S

Brand Name

VYGON

Version/Model Number

VYAA21G7S

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

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

d9049563-e521-4e8c-9f45-d08a2c991fbd

Public Version Date

April 16, 2019

Public Version Number

1

DI Record Publish Date

April 08, 2019

Package DI Number

38498840011318

Quantity per Package

10

Contains DI Package

08498840011317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-