Catalog Number

-

Brand Name

FLIXENE SLIDER GDS

Version/Model Number

25070

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 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"

-

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

DSY

Product Code Name

PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Public Device Record Key

d5d87b12-f0e0-49a6-ae8f-d0af34274531

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-