MicroCell - MicroCell, 20um, 4-Chamber - VITROLIFE INC.

Duns Number:051915038

Device Description: MicroCell, 20um, 4-Chamber

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More Product Details

Catalog Number

-

Brand Name

MicroCell

Version/Model Number

15424

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

GHO

Product Code Name

Hemocytometer

Device Record Status

Public Device Record Key

e17f8573-fc1f-46c2-a470-1a078b21b332

Public Version Date

April 29, 2020

Public Version Number

3

DI Record Publish Date

April 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VITROLIFE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 38