AlVeo 510354

GUDID 10850014593640

The alVeo 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: 10850014593640
• NIH Device Record Key: 0ffe0271-606b-48de-b6c5-bf4873464e5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlVeo
• Version Model Number: 510354
• Catalog Number: 510354
• 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
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: 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	00850014593643 [Primary]
GS1	10850014593640 [Package]; Contains: 00850014593643; 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: 2023-02-20 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: 2023-02-20The alVeo 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.
• 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