Catalog Number

AMS-8368

Brand Name

VYGON

Version/Model Number

AMS-8368

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

c7abee34-5c4b-44d2-949b-a4918ed40560

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 07, 2016

Package DI Number

38498840003528

Quantity per Package

20

Contains DI Package

08498840003527

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-