Multipurpose Handling Medium®-Complete (MHM®-C) - Multipurpose Handling Medium®-Complete (MHM®-C) - FUJIFILM IRVINE SCIENTIFIC, INC.

Duns Number:057475246

Device Description: Multipurpose Handling Medium®-Complete (MHM®-C) with Gentamicin

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More Product Details

Catalog Number

90166

Brand Name

Multipurpose Handling Medium®-Complete (MHM®-C)

Version/Model Number

90166-12x12mL

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

Yes

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

-

FDA Premarket Submission

K121128,K121128

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

05c66b2e-4e8d-4f76-9b9b-334f780f5329

Public Version Date

February 13, 2019

Public Version Number

2

DI Record Publish Date

October 01, 2018

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