Dr.PRP

Basic Information

• Brand Name: Dr.PRP
• Primary DI: 08809410200060
• Version / Model: Dr.PRP
• Catalog Number: RMLFT-001(EN)
• Company Name: Rmedica Co.,Ltd
• Labeler DUNS: 694634708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-03
• Public Version: 4
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: 1353fe92-e2d9-4553-9313-ccd6e059bd4e

Device Description

The Dr. PRP is an individually packaged sterile, single-use, disposable concentrating unit composed of medical-grade polymer and elastomer. The concentrating unit has 20ml of volume capacity and is designed to work with a sing rotor type general-purpose centrifuge.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47183	Haematological concentrate system	An assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, the concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809410200060	GS1
Package	08809410200008	GS1	Inner box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK230818	0

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 35.6 – 86 Degrees Fahrenheit