Catalog Number

K-EBPH-3035

Brand Name

Cook

Version/Model Number

G32795

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

MQH

Product Code Name

MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)

Public Device Record Key

63fbb998-c9cd-4e95-8865-ce8e980a5b07

Public Version Date

June 20, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10827002327952

Quantity per Package

10

Contains DI Package

00827002327955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-