Quinn's Advantage Medium With HEPES - Quinn's Advantage Medium With HEPES. 50 ml - Origio A/S

Duns Number:305424269

Device Description: Quinn's Advantage Medium With HEPES. 50 ml

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More Product Details

Catalog Number

-

Brand Name

Quinn's Advantage Medium With HEPES

Version/Model Number

ART-1022

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2018

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

-

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

9d457922-6706-4a0a-9ba5-4bfbfb00a099

Public Version Date

April 19, 2018

Public Version Number

3

DI Record Publish Date

July 28, 2016

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