MAXX PRP MXPRP-1
GUDID 10850014593374
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.
ROYAL BIOLOGICS INC.
Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration| Primary Device ID | 10850014593374 |
| NIH Device Record Key | aa34ab7b-4a1e-45a8-997a-402aaad1f859 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAXX PRP |
| Version Model Number | MXPRP |
| Catalog Number | MXPRP-1 |
| Company DUNS | 080562141 |
| Company Name | ROYAL BIOLOGICS INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com | |
| Phone | +1 201-488-1549 |
| support@royalbiologics.com |
Device Dimensions
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850014593377 [Primary] |
| GS1 | 10850014593374 [Package] Contains: 00850014593377 Package: case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- BK210563
FDA Product Code
| ORG | Platelet And Plasma Separator For Bone Graft Handling |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-20 |
| Device Publish Date | 2021-05-12 |
Devices Manufactured by ROYAL BIOLOGICS INC.
| 00850014593018 - FIBRINET | 2023-02-20 The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® System is designed to be used for the |
| 00850014593025 - FIBRINET | 2023-02-20 The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a |
| 00850014593032 - FIBRINET | 2023-02-20 The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a |
| 10850014593626 - BioIncyte | 2023-02-20 The BioIncyte Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platel |
| 10850014593633 - SeriVium | 2023-02-20 The SeriVium Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platele |
| 10850014593640 - AlVeo | 2023-02-20 The alVeo Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-r |
| 00850014593650 - Bio-Reign 3D | 2023-02-20 Bio-Reign 3D Granules 5cc |
| 00850014593667 - Bio-Reign 3D | 2023-02-20 Bio-Reign 3D Granules 10cc |
Trademark Results [MAXX PRP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAXX PRP 97587247 not registered Live/Pending |
Royal Biologics 2022-09-12 |
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