PureCeption 24 - Determination Bi-Layer Kit - PureCeption 24 - Determination Bi-Layer Kit. 6x12 - Origio A/S

Duns Number:305424269

Device Description: PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase In HEPES-buffered HTF

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More Product Details

Catalog Number

-

Brand Name

PureCeption 24 - Determination Bi-Layer Kit

Version/Model Number

ART-2024

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"

-

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 Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

d25b026a-d599-458f-b6d8-c6932a0133e5

Public Version Date

March 29, 2018

Public Version Number

2

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