Catalog Number

75004516

Brand Name

Thermo Scientific

Version/Model Number

Heraeus Multifuge X3R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KSO

Product Code Name

Centrifuge, Blood-Bank For In Vitro Diagnostic Use

Public Device Record Key

a2b6bf00-cc3b-4ea7-af4f-7b45e9fb185f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-