Catalog Number

-

Brand Name

Kryo ART Freezer

Version/Model Number

GDKRYOART-3.3-115

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 13, 2017

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MQG

Product Code Name

Accessory, Assisted Reproduction

Public Device Record Key

b698a37e-8ab3-4b7c-a40b-17dc0e001997

Public Version Date

October 28, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-