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

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

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.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn.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 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