Autologous Platelet Concentrate+ (APC) Procedure Pack, APC
HARVEST® - 51405
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
- 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and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn.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 IdentifiersDevice Id: 05020583514058
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: 35020583514059
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05020583514058
Package Quantity: 6
Package Discontinue Date: 2/14/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
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