Catalog Number

IGTCFS-65-1-UNI-CELECT

Brand Name

Cook Celect

Version/Model Number

G52915

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K090140

Product Code

DTK

Product Code Name

FILTER, INTRAVASCULAR, CARDIOVASCULAR

Public Device Record Key

606865f2-3601-491d-972a-d157f838d126

Public Version Date

October 29, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-