Thermo Fisher - 100-240V 50/60HZ WITHOUT STARTER KIT - THERMO SHANDON LIMITED

Duns Number:219103512

Device Description: 100-240V 50/60HZ WITHOUT STARTER KIT

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More Product Details

Catalog Number

-

Brand Name

Thermo Fisher

Version/Model Number

Cytospin 4 EX Demo

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)

-

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

IFB

Product Code Name

Cytocentrifuge

Device Record Status

Public Device Record Key

f6295dec-b699-4a06-b214-00593947c662

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERMO SHANDON LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 147