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ASCENT FLEXXBMC

Primary DI
G668FG0020
Brand
ASCENT FLEXXBMC
Company
ORTHOASCENT, LLC
Model
FG-002 Bone Marrow Concentrate (BMC)
Device description
The FG-002 Bone Marrow Concentrate (BMC) Device is a single-use, sterile concentrating device. It concentrates autologous bone marrow aspirate using a centrifuge.
Published
2026-01-05
Public version status
Update
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
G668FG0021PackageHIBCC8In Commercial Distribution
G668FG0022PackageHIBCC2In Commercial Distribution
G668FG0023PackageHIBCC4In Commercial Distribution
G668FG0024PackageHIBCC6In Commercial Distribution
G668FG0020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, bone marrow concentrationA collection of sterile devices typically used at the point-of-care for the rapid preparation of autologous bone marrow aspirate concentrate (BMAC) from bone marrow aspirate. The kit components, with the bone marrow aspirate, are directly placed in a dedicated centrifuge that separates and concentrates the bone marrow. The cellular BMAC preparations are typically applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. The kit may include specimen drawing devices. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119273976
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
G668FG0011ASCENT FLEXXPRP FG-001 Platelet Rich Plasma (PRP) 2026-01-05
G668FG0021ASCENT FLEXXBMCFG-002 Bone Marrow Concentrate (BMC)2026-01-05
G668FG0160BMC Device MasterpackFG-016 BMC Device Masterpack2026-01-05

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