Catalog Number

AMS-8226

Brand Name

VYGON

Version/Model Number

AMS-8226

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

OVN

Product Code Name

Suture kit

Public Device Record Key

18754d5b-dd0c-4738-9fcf-63dfd2d0ca17

Public Version Date

April 06, 2020

Public Version Number

1

DI Record Publish Date

March 27, 2020

Package DI Number

30849884003186

Quantity per Package

20

Contains DI Package

00849884003185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-