Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60 Procedure Pack


Product Overview

Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC
HARVEST® - 51406


Device Description

A 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.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: ORG

    Device Name: Platelet And Plasma Separator For Bone Graft Handling

    Device Class: 2

    Physical State: May include centrifuge, filters, tubes, syringes and needles

    Definition: Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.

    Submission Type ID: 1

    Review Panel: HE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Uses centrifugal and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Blood drawn from peripheral veins, PRP applied to bony defects

    Regulation Number: 864.9245

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 05020583514065

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 35020583514066

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 05020583514065

    Package Quantity: 3

    Package Discontinue Date: 2/14/2023 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: N/A


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