Catalog Number

T8005

Brand Name

MAXIFLO™

Version/Model Number

T8005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 30, 2019

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"

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

-

Product Code

DYF

Product Code Name

PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER

Public Device Record Key

14354d07-40c7-4d49-b46a-f1b8e397ecb4

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 19, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-