Chang Medium® C with Gentamicin - Chang Medium C with Gentamicin - FUJIFILM IRVINE SCIENTIFIC, INC.

Duns Number:057475246

Device Description: Chang Medium C with Gentamicin

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More Product Details

Catalog Number

99418

Brand Name

Chang Medium® C with Gentamicin

Version/Model Number

99418-450mL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2020

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KIT

Product Code Name

Media And Components, Synthetic Cell And Tissue Culture

Device Record Status

Public Device Record Key

6fb3a5da-26f1-4c26-a402-340146d9d03c

Public Version Date

September 30, 2020

Public Version Number

4

DI Record Publish Date

December 31, 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