Catalog Number

AMS-9849-1

Brand Name

VYGON

Version/Model Number

AMS-9849-1

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

KDD

Product Code Name

Kit, surgical instrument, disposable

Public Device Record Key

08bd43c8-f445-4e48-93a4-d9822b97c120

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

December 09, 2020

Package DI Number

30849884002073

Quantity per Package

20

Contains DI Package

00849884002072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-