Catalog Number

AMS-7656

Brand Name

VYGON

Version/Model Number

AMS-7656

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

K141026,K141026

Product Code

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Public Device Record Key

318457e1-0572-48af-8733-4a59186f28d0

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 26, 2019

Package DI Number

38498840011653

Quantity per Package

10

Contains DI Package

08498840011652

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-