ASCENT FLEXXPRP

Primary DI
G668FG0010
Brand
ASCENT FLEXXPRP
Company
ORTHOASCENT, LLC
Model
FG-001 Platelet Rich Plasma (PRP)
Device description
The Platelet Rich Plasma (PRP) Device is a single-use, sterile concentrating device. It concentrates blood components and aids in the separation of the blood components by density using a centrifuge. The PRP prepared by this device has not been evaluated for any clinical indications. The PRP prepared by this device is NOT indicated for delivery to the patient’s circulatory system.
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
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK2410830

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2410830

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G668FG0011PackageHIBCC8In Commercial Distribution
G668FG0012PackageHIBCC2In Commercial Distribution
G668FG0013PackageHIBCC4In Commercial Distribution
G668FG0014PackageHIBCC6In Commercial Distribution
G668FG0010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Autologous platelet-based product centrifuge tubeA small, cylindrical container intended to temporarily store venous blood and subsequently placed in a centrifuge to produce platelet rich fibrin (PRF) or platelet rich plasma (PRP) for application to the patient from whom the blood was taken (typically for mixing with bone graft to repair bone defects and/or application to skin wounds to accelerate healing and/or achieve haemostasis). It typically includes a lid intended to be pierced with a syringe needle for blood infusion and PRF/PRP withdrawal, clot activator (e.g., silica) and/or filter for isolation of the PRF/PRP, and a rotation mechanism facilitated by centrifugation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119273976
Device count
1
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
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
G668FG0160BMC Device MasterpackFG-016 BMC Device Masterpack2026-01-05

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Primary DI, Brand, Company table
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