Early Cleavage Medium - Early Cleavage Medium (ECM) with Gentamicin - FUJIFILM IRVINE SCIENTIFIC, INC.

Duns Number:057475246

Device Description: Early Cleavage Medium (ECM) with Gentamicin

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More Product Details

Catalog Number

90138

Brand Name

Early Cleavage Medium

Version/Model Number

90138-60mL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 29, 2022

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K033462

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

2f562a57-4d2f-48aa-9beb-7e77d1997335

Public Version Date

April 29, 2022

Public Version Number

6

DI Record Publish Date

September 10, 2016

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