Identity
- Trade Name
- ProGen PRP Eclipse FDA UDI
- Generic Name
- Autologous platelet-based product centrifuge tube FDA UDI
- Device Name
- 15mL Platelet Rich Plasma production device FDA UDI
- Model / Reference
- P5PG052 FDA UDI
- Description
- 15mL Platelet Rich Plasma production device FDA UDI
Identifiers
- Catalog Number
- PROGEN-A15 FDA UDI
- Primary DI / UDI-DI
- 00850060751110 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Autologous platelet-based product centrifuge tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Autologous platelet-based product centrifuge tube
ProGen PRP Eclipse by Bellus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK170136 also covers:
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- ProGen PRP Advantage — Bimini Technologies LLC
- ProGen PRP Advantage — Bimini Technologies LLC
- ProGen PRP Eclipse — Bimini Technologies LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bellus Medical, Llc
Sources (1)
- FDA UDI 307c22d5-9a3b-4b48-a888-0eb074330f9a 36 fields · synced May 30, 2026