Catalog Number

IGTCFS-65-8.5-1-FEM-CELECT

Brand Name

Cook Celect

Version/Model Number

G03767

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2018

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

DTK

Product Code Name

FILTER, INTRAVASCULAR, CARDIOVASCULAR

Public Device Record Key

c9dfac55-6d6a-45c8-b24c-6f4a2db5d13b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-