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BMC Device Masterpack

Primary DI
G668FG0160
Brand
BMC Device Masterpack
Company
ORTHOASCENT, LLC
Model
FG-016 BMC Device Masterpack
Device description
The BMC Device Master Pack is a corrugated container that is composed of the following: 1 case of 8 FG-002 BMC Devices1 QA-LBL-004 BMC Device IFU8 FG-005 BMC Draw Kits8 FG-006 BMC Processing Kits
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
G668FG0160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate systemAn assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, the concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119273976
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G668FG0010ASCENT FLEXXPRP FG-001 Platelet Rich Plasma (PRP) 2026-01-05
G668FG0020ASCENT FLEXXBMCFG-002 Bone Marrow Concentrate (BMC)2026-01-05
G668FG0011ASCENT FLEXXPRP FG-001 Platelet Rich Plasma (PRP) 2026-01-05
G668FG0021ASCENT FLEXXBMCFG-002 Bone Marrow Concentrate (BMC)2026-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10850044310255Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
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00664816006030LW Scientific, Inc`LW SCIENTIFIC, INC.JQC2026-03-02
00664816006016LW ScientificLW SCIENTIFIC, INC.JQC2026-02-20
00664816005682LW Scientific, Inc.LW SCIENTIFIC, INC.JQC2026-02-16
00810052864945642M Centrifuge, AccuReferenceDRUCKER DIAGNOSTICSJQC2026-02-02
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