Quinns Advantage Embryo Freeze Kit - Quinns Advantage Embryo Freeze Kit. 5x12 ml - Origio A/S

Duns Number:305424269

Device Description: Quinns Advantage Embryo Freeze Kit. 5x12 ml

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More Product Details

Catalog Number

-

Brand Name

Quinns Advantage Embryo Freeze Kit

Version/Model Number

ART-8014

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2020

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"

-

For Single-Use

Yes

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 Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

e12b1205-e69c-4bd0-998f-3ba4bc710b57

Public Version Date

October 15, 2020

Public Version Number

3

DI Record Publish Date

March 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORIGIO A/S" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 93