Catalog Number

AMS-9810

Brand Name

VYGON

Version/Model Number

AMS-9810

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

ec9d3647-28c9-4be0-a6d1-660e4266ded1

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

38498840009797

Quantity per Package

20

Contains DI Package

08498840009796

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-