Bio-Reign 3D BR-s25x75x5

GUDID 00850014593759

Bio-Reign 3D Sheet 25mm x 75mm x 5mm

ROYAL BIOLOGICS INC.

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 00850014593759
• NIH Device Record Key: 16fa4dc8-466a-448c-b316-6b78be3cca6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Reign 3D
• Version Model Number: BR-s25x75x5
• Catalog Number: BR-s25x75x5
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

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	00850014593759 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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

On-Brand Devices [Bio-Reign 3D]

• 00850014593773: Bio-Reign 3D Block 14mm x 10mm x 14mm
• 00850014593766: Bio-Reign 3D Sheet 25mm x 125mm x 5mm
• 00850014593759: Bio-Reign 3D Sheet 25mm x 75mm x 5mm
• 00850014593742: Bio-Reign 3D Sheet 25mm x 50mm x 5mm
• 00850014593735: Bio-Reign 3D Sheet 25mm x 25mm x 5mm
• 00850014593728: Bio-Reign 3D Sheet 25mm x 125mm x 3mm
• 00850014593711: Bio-Reign 3D Sheet 25mm x 75mm x 3mm
• 00850014593704: Bio-Reign 3D Sheet 25mm x 50mm x 3mm
• 00850014593698: Bio-Reign 3D Sheet 25mm x 25mm x 3mm
• 00850014593681: Bio-Reign 3D Granules 30cc
• 00850014593674: Bio-Reign 3D Granules 20cc
• 00850014593667: Bio-Reign 3D Granules 10cc
• 00850014593650: Bio-Reign 3D Granules 5cc