ProGen PRP Eclipse

Basic Information

• Brand Name: ProGen PRP Eclipse
• Primary DI: 00850060751158
• Version / Model: P5PG053
• Catalog Number: PROGEN-A30
• Company Name: Bellus Medical, LLC
• Labeler DUNS: 005677967
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-28
• Public Version: 4
• Public Version Date: 2025-11-14
• Public Version Status: Update
• Public Device Record Key: 2ef38969-d280-4e07-92e0-1763ba807a6b

Device Description

30mL Platelet Rich Plasma production device

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: Yes
• 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: No
• 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
61377	Autologous platelet-based product centrifuge tube	A small, cylindrical container intended to temporarily store venous blood and subsequently placed in a centrifuge to produce platelet rich fibrin (PRF) or platelet rich plasma (PRP) for application to the patient from whom the blood was taken (typically for mixing with bone graft to repair bone defects and/or application to skin wounds to accelerate healing and/or achieve haemostasis). It typically includes a lid intended to be pierced with a syringe needle for blood infusion and PRF/PRP withdrawal, clot activator (e.g., silica) and/or filter for isolation of the PRF/PRP, and a rotation mechanism facilitated by centrifugation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850060751172	GS1	Box	3	In Commercial Distribution
Primary	00850060751158	GS1
Package	10850060751179	GS1	Shipper	6	In Commercial Distribution
Package	00850060751202	GS1	Shipper	4	In Commercial Distribution
Package	00850060751493	GS1	Box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK170136	0