ICSI Cumulase - ICSI Cumulase. 5x0.5 ml - Origio A/S

Duns Number:305424269

Device Description: ICSI Cumulase. 5x0.5 ml

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More Product Details

Catalog Number

-

Brand Name

ICSI Cumulase

Version/Model Number

16125000D

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

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

K081639,K081639

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

f2a79f03-48f5-4703-a465-8a8ad5fb96ae

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 22, 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