Arctic Sperm Cryopreservation Medium - Arctic Sperm Cryopreservation Medium - FUJIFILM IRVINE SCIENTIFIC, INC.

Duns Number:057475246

Device Description: Arctic Sperm Cryopreservation Medium

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More Product Details

Catalog Number

90170

Brand Name

Arctic Sperm Cryopreservation Medium

Version/Model Number

90170-12x5mL

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

K171224,K171224

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

606211e4-1953-4c1b-991c-d3f77b767802

Public Version Date

February 13, 2019

Public Version Number

4

DI Record Publish Date

December 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FUJIFILM IRVINE SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 52