FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867334786
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-10017
Catalog number
ABS-10017
Device description
ACP Max Counterbalance
Published
2023-03-16
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
JQOBALANCE, ANALYTICAL
ORGPlatelet and plasma separator for bone graft handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQOBalance, AnalyticalClinical Chemistry1
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867334786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867334786008888673347868888673347860888867334786

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867473553Arthrex®AR-1288QAI-100AR-1288QAI-1002025-03-18
00888867473560Arthrex®AR-1288QAI-110AR-1288QAI-1102025-03-18
00888867473577Arthrex®AR-1288QAI-80AR-1288QAI-802025-03-18
00888867473584Arthrex®AR-1288QAI-90AR-1288QAI-902025-03-18
00888867473638Arthrex®AR-1288QTT-100AR-1288QTT-1002025-03-18
00888867473645Arthrex®AR-1288QTT-110AR-1288QTT-1102025-03-18
00888867473652Arthrex®AR-1288QTT-80AR-1288QTT-802025-03-18
00888867473669Arthrex®AR-1288QTT-90AR-1288QTT-902025-03-18
00888867034372Arthrex®AR-502-1LAR-502-1L2017-02-15
00888867034389Arthrex®AR-502-1RAR-502-1R2017-02-15
00888867034396Arthrex®AR-502-2LAR-502-2L2017-02-15
00888867034402Arthrex®AR-502-2RAR-502-2R2017-02-15
00888867034570Arthrex®AR-502-3LAR-502-3L2017-02-15
00888867034587Arthrex®AR-502-3RAR-502-3R2017-02-15
00888867034662Arthrex®AR-502-4LAR-502-4L2017-12-06
00888867034679Arthrex®AR-502-4RAR-502-4R2017-02-15
00888867035546Arthrex®AR-504-PSA8AR-504-PSA82017-02-15
00888867035560Arthrex®AR-504-PSC9AR-504-PSC92017-02-15
00888867035577Arthrex®AR-504-PSD0AR-504-PSD02017-02-15
00888867106840Arthrex®AR-504-PSE0AR-504-PSE02017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719875912283Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2026-09-24
04719875912290Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2026-09-24
04719875912306Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2026-09-24
04719875912276Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2026-06-22
08685139210029Centrifuge Container SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-04-10
00850083564001MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564025MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564049GoldrushBahia Medical Inc.ORG2026-04-03
00850083564056GoldrushBahia Medical Inc.ORG2026-04-03
00850083564063GenesisBahia Medical Inc.ORG2026-04-03
00850023741561CERVOS PLATELET SEPARATOR 80 KITRANFAC CORP.ORG2026-03-30
00850075308088CER-PRP-160 STERILITY PACKRANFAC CORP.ORG2026-03-30
00850075308101CER-PRP-160 KitRANFAC CORP.ORG2026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILERANFAC CORP.ORG2026-03-30
B708XCPC120XCELLAPEX BIOLOGIX , LLCORG2026-03-26
B708XCPC60XCELLAPEX BIOLOGIX , LLCORG2026-03-26
00850033131215RegenKit®-BCT-T-URegenlab USA LLCORG2026-03-25
08685139210036Exocube SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210012ExoCubeEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210067ExoCube-20PackEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08809410200046Dr.PRPRmedica Co.,LtdORG2026-02-02
08809410200053Dr.PRPRmedica Co.,LtdORG2026-02-02
G668FG0010ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
G668FG0011ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFIDIA FARMACEUTICI SPAORG2025-10-31
00850075308095CER-PRP-SINGLE-ARANFAC CORP.ORG2025-10-08
04719875912245Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
04719875912252Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912242Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912259Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07