Catalog Number

800-0512

Brand Name

Plasmax® Plus Counterbalance

Version/Model Number

800-0512

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JQC

Product Code Name

CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Public Device Record Key

544b6fd4-3787-41b7-9e43-a1dab2cd31f3

Public Version Date

October 07, 2020

Public Version Number

3

DI Record Publish Date

June 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-