FDA.reportPublic FDA data

Plasmax® Counterbalance

Primary DI
00880304400092
Brand
Plasmax® Counterbalance
Company
Biomet Biologics, LLC
Model
800-0510
Catalog number
800-0510
Published
2019-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304400092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304400092008803044000928803044000920880304400092

GMDN Terms#

Term, Definition table
TermDefinition
Centrifuge tube counterbalanceA device in the form of a centrifuge tube intended to balance weight across a centrifuge rotor when processing uneven numbers of tubes or tubes containing different volumes of fluid. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
802003074
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350023774307Calcibon401163000140116300012025-10-09
00880304640962Bilateral BMA Kit800-0710800-07102021-10-30
00887868284830Calcigen® S Bone Graft System3480103480102019-01-11
00887868284847Calcigen® S Bone Graft System3480123480122019-01-11
00887868284854Calcigen® S Bone Graft System3480143480142019-01-11
00880304443112Plasmax® Plus Counterbalance800-0512800-05122019-06-11
00880304484757Biomet®800-0270800-02702019-06-11
00887868306730Biomet® Biologics800-0274800-02742019-06-11
00887868263033Perfuse™ Decompression System800-0542800-05422019-04-18
00880304451759BMA Kit800-0705800-07052019-02-22
00880304460645GPS® III800-0744800-07442016-11-03
00880304460652GPS® III800-0745800-07452016-11-03
00880304508781BIOMET® BIOLOGICS800-0274800-02742016-11-03
00880304521513GPS®III Mini Platelet Concentration System800-0505A800-0505A2018-11-13
00880304640856Plasmax® Plasma Concentration Kit800-0516800-05162018-11-27
00880304640917BioCUE®800-0614800-06142016-11-03
00880304640924BioCUE®800-0615800-06152016-11-03
00880304641068GPS® III PLATELET CONCENTRATION SYSTEM800-1006A800-1006A2016-11-03
00880304680333PERFUSE DECOMPRESSION INSTRUMENTATION800-0546800-05462016-11-03
00880304681446Plasmax® Plus Plasma Concentration Kit800-0517800-05172018-11-27

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Primary DI, Brand, Company table
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10850044310255Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310286Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
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G668FG0020ASCENT FLEXXBMCORTHOASCENT, LLCJQC2026-01-05