642E Centrifuge, Precision Health - General purpose laboratory centrifuge for sample - DRUCKER DIAGNOSTICS

Duns Number:022156957

Device Description: General purpose laboratory centrifuge for sample separation.

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More Product Details

Catalog Number

00-018-139-000

Brand Name

642E Centrifuge, Precision Health

Version/Model Number

00-018-139-000

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

JQC

Product Code Name

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Device Record Status

Public Device Record Key

294efd8b-9640-4add-81e3-66f7fc37e4ba

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 26, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRUCKER DIAGNOSTICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 351
2 A medical device with a moderate to high risk that requires special controls. 31