BioIncyte 510356
GUDID 10850014593626
The BioIncyte Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
ROYAL BIOLOGICS INC.
Haematological concentrate system preparation kit, platelet concentration| Primary Device ID | 10850014593626 |
| NIH Device Record Key | fa1e496c-064a-4021-b26d-688b15b5c05f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioIncyte |
| Version Model Number | 510356 |
| Catalog Number | 510356 |
| 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 | |
| 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 |
| 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 |
| 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 | 00850014593629 [Primary] |
| GS1 | 10850014593626 [Package] Contains: 00850014593629 Package: case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- BK120008
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 | 2023-02-20 |
| Device Publish Date | 2023-02-10 |
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 | 2023-02-20The BioIncyte Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. |
| 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 [BioIncyte]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOINCYTE 97618622 not registered Live/Pending |
Royal Biologics 2022-10-04 |
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