FDA.report

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 Devices 1 QA-LBL-004 BMC Device IFU 8 FG-005 BMC Draw Kits 8 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
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
G668FG0160PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
119273976
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
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

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