Catalog Number

FDB5.3-35-40

Brand Name

Cook

Version/Model Number

G09278

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2017

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)

Yes

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

DYG

Product Code Name

CATHETER, FLOW DIRECTED

Public Device Record Key

0baab7f5-3a3f-4bf4-b7f0-fa4ef1d618ef

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-