Catalog Number

VAT5507

Brand Name

VYGON

Version/Model Number

VAT5507

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

bdbbdebe-959a-4bc8-8972-3dbbc66f5332

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

April 08, 2019

Package DI Number

38498840011783

Quantity per Package

20

Contains DI Package

08498840011782

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-