MARGENIX

Basic Information

• Brand Name: MARGENIX
• Primary DI: 00850083564025
• Version / Model: MARG2
• Catalog Number: MARG2
• Company Name: Bahia Medical Inc.
• Labeler DUNS: 119362037
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-03
• Public Version: 1
• Public Version Date: 2026-04-13
• Public Version Status: New
• Public Device Record Key: 7c966e5c-077e-4e4e-8bb5-cb0e1c944323

Device Description

PRP2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
Package	00850083564032	GS1		5	In Commercial Distribution
Primary	00850083564025	GS1