RICHPLAT ORTHO 40 PRP SYSTEM

Primary DI
M713FPRP400
Brand
RICHPLAT ORTHO 40 PRP SYSTEM
Company
FIDIA FARMACEUTICI SPA
Model
FPRP40
Catalog number
FPRP40
Device description
The RICHPLAT ORTHO® 40 Platelet Rich Plasma System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
Published
2025-10-31
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

Contact Domains#

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
BK1802960

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1802960

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M713FPRP401PackageHIBCC10In Commercial Distribution
M713FPRP400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
973-577-6202regulatory@fidiapharma.us

Regulatory Flags#

DUNS number
428453013
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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