Catalog Number

M00201501045B0

Brand Name

Fusion Bioline Vascular Grafts

Version/Model Number

M00201501045B0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

K131778

Product Code

DSY

Product Code Name

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Public Device Record Key

51d88238-ac2f-4841-840a-59a1e69e36b9

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-