Vitrification Media - Contains BS x 1, ES x 1, and VS x 2 - KITAZATO CORPORATION

Duns Number:711091157

Device Description: Contains BS x 1, ES x 1, and VS x 2

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More Product Details

Catalog Number

91103

Brand Name

Vitrification Media

Version/Model Number

VT601US

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

-

Product Code Details

Product Code

MQL

Product Code Name

MEDIA, REPRODUCTIVE

Device Record Status

Public Device Record Key

6b99ecb6-24d8-4f82-8506-a6052ee4154a

Public Version Date

January 08, 2020

Public Version Number

2

DI Record Publish Date

August 03, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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