Identity
- Trade Name
- MAXX PRP FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- The Royal MAXX™ PRP concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood 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 phlebotomy supplies. FDA UDI
- Model / Reference
- MXPRP FDA UDI
- Description
- The Royal MAXX™ PRP concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood 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 phlebotomy supplies. FDA UDI
Identifiers
- Catalog Number
- MXPRP-1 FDA UDI
- Primary DI / UDI-DI
- 00850014593377 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 Prp by Royal Biologics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haematological concentrate system preparation kit, platelet concentration.
- RegenPlasma/RegenKit-Woud Gel-2 — REGEN LAB SA · Class II
- Magellan Complete Disposable Kit — Arteriocyte Medical Systems, Inc.
- Transcend PRP — AEON BIOTHERAPEUTICS CORP. · Class II
- MAR0Max Convenience kit — Arteriocyte Medical Systems, Inc.
- RegenKit-BCT-3 (20ml)/RegenPlasma — REGEN LAB SA · Class II
- Virtue CPKit — AEON BIOTHERAPEUTICS CORP. · Class II
- Precise Sapphire — Arteriocyte Medical Systems, Inc. · Class II
- Precise — Arteriocyte Medical Systems, Inc. · Class II
Cleared under the same submission
BK210563 also covers:
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
- Royal Biologics, Inc.
Sources (1)
- FDA UDI aa34ab7b-4a1e-45a8-997a-402aaad1f859 38 fields · synced May 30, 2026