Catalog Number

ECH060010A

Brand Name

GORE ACUSEAL Vascular Graft

Version/Model Number

ECH060010A

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

Yes

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

-

FDA Premarket Submission

K130215

Product Code

DSY

Product Code Name

PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Public Device Record Key

f1fda987-e437-46e2-ba8d-0d02638ac45a

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-