Catalog Number

ATC6028

Brand Name

AlboGraft Polyester Vascular Graft

Version/Model Number

ATC6028

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

K093231,K103080

Product Code

MAL

Product Code Name

Graft, Vascular, Synthetic/Biologic Composite

Public Device Record Key

df29b490-ab46-4ea1-9740-5bd4673c9c19

Public Version Date

April 21, 2021

Public Version Number

5

DI Record Publish Date

November 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-