Catalog Number

AG 645

Brand Name

Artegraft Vascular Graft

Version/Model Number

AG 645

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

N16837

Product Code

LXA

Product Code Name

Tissue Graft Of 6mm And Greater

Public Device Record Key

c4d57b45-2152-459f-931b-a112ddecc523

Public Version Date

April 21, 2021

Public Version Number

5

DI Record Publish Date

August 29, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-