FDA.report

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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G668FG0021PackageHIBCC8In Commercial Distribution
G668FG0022PackageHIBCC2In Commercial Distribution
G668FG0023PackageHIBCC4In Commercial Distribution
G668FG0024PackageHIBCC6In Commercial Distribution
G668FG0020PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
119273976
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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