Identity
- Trade Name
- MAXX BMC FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- The Royal MAXX™ BMC concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of a mixture of peripheral blood and bone marrow aspirate at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and bone marrow aspiration supplies. FDA UDI
- Model / Reference
- MXBMC-60 FDA UDI
- Description
- The Royal MAXX™ BMC concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of a mixture of peripheral blood and bone marrow aspirate at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and bone marrow aspiration supplies. FDA UDI
Identifiers
- Catalog Number
- MXBMC-60 FDA UDI
- Primary DI / UDI-DI
- 00850014593391 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 60 Milliliter FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentration
Maxx Bmc by Royal Biologics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Royal Biologics, Inc.
Sources (1)
- FDA UDI f4c4917c-71df-4321-a215-d286e7ae9cdd 38 fields · synced Jun 1, 2026