Catalog Number

81174

Brand Name

Cryotop US(B)

Version/Model Number

Cryotop US(B)

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

K153027,K153027

Product Code

MQK

Product Code Name

LABWARE, ASSISTED REPRODUCTION

Public Device Record Key

43292d6c-f192-467d-8efb-421995ff1342

Public Version Date

January 08, 2020

Public Version Number

2

DI Record Publish Date

July 27, 2018

Package DI Number

14582231462923

Quantity per Package

10

Contains DI Package

04582231462926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-