Heavy Oil for Embryo Culture - Heavy Oil for Embryo Culture - FUJIFILM IRVINE SCIENTIFIC, INC.

Duns Number:057475246

Device Description: Heavy Oil for Embryo Culture

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More Product Details

Catalog Number

90189

Brand Name

Heavy Oil for Embryo Culture

Version/Model Number

90189-100mL

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K011938

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

4e7ef568-35ff-48d4-be66-e20fcc3cec00

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

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