CryotopUS-scoop(G) - Cryopreservation storage devices that are - KITAZATO CORPORATION

Duns Number:711091157

Device Description: Cryopreservation storage devices that are intended for use in vitrificationprocedures to c Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.

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More Product Details

Catalog Number

81195

Brand Name

CryotopUS-scoop(G)

Version/Model Number

CryotopUS-scoop(G)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181469,K181469

Product Code Details

Product Code

MQK

Product Code Name

LABWARE, ASSISTED REPRODUCTION

Device Record Status

Public Device Record Key

e3dd5639-9bc7-4cee-915d-95ee21288ee6

Public Version Date

January 08, 2020

Public Version Number

2

DI Record Publish Date

June 01, 2019

Additional Identifiers

Package DI Number

14582231462848

Quantity per Package

10

Contains DI Package

04582231462841

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"KITAZATO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 177