Catalog Number

-

Brand Name

CryotopUS(W)

Version/Model Number

CryotopUS(W)

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MQK

Product Code Name

LABWARE, ASSISTED REPRODUCTION

Public Device Record Key

bbaf13b6-9f00-40b6-b7d1-43da963bba97

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 08, 2016

Package DI Number

14582231462497

Quantity per Package

10

Contains DI Package

04582231462490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-