Regenerative Medicine
Pure TWO PRP
Dual-spin autologous PRP system for precision platelet concentration.
Manufacturer
EmCyte®
Classification
FDA 510(k) Cleared
Storage
Refrigerate 2–8°C
Draw Volumes
| Draw | Concentrate |
|---|---|
| 22 mL whole blood | ~3 mL PRP |
| 60 mL whole blood | ~8 mL PRP |
Overview
Pure TWO PRP is an FDA 510(k) cleared dual-spin platelet-rich plasma system by EmCyte®. The two-step centrifugation protocol produces a highly refined PRP concentrate with consistent platelet recovery. Designed for providers who require precise control over platelet concentration and leukocyte content.
Key Features & Benefits
- FDA 510(k) cleared dual-spin PRP system
- Two-step protocol for refined platelet concentrate
- Consistent platelet recovery across draws
- Leukocyte-controlled formulation options
- Compatible with Sapphire Series centrifuge
- Autologous preparation from patient’s own blood
Indications for Use
Autologous platelet-rich plasma preparation for use in regenerative medicine procedures as directed by a licensed healthcare provider. For professional use only. Not for systemic administration.
Mechanism of Action
Pure TWO PRP is an FDA 510(k) cleared medical device. The dual-spin protocol separates whole blood components to produce a refined PRP concentrate. Ridge Biologics does not make clinical efficacy claims. Use should be based on healthcare provider judgment and manufacturer labeling.
Regulatory & Compliance
Regulatory Framework
FDA 510(k) Cleared
Application
Autologous point-of-care processing
Handling
Whole blood: room temp; concentrate: 2–8°C
Distributor License
Ridge Biologics, Utah DOPL
Refer to the manufacturer’s package insert for complete indications, contraindications, warnings, precautions, and instructions for use. Ridge Biologics is an authorized distributor and does not modify, manipulate, or repackage products. Distribution to licensed healthcare providers only.