Mg OSTEOREVIVE® Bone Void Filler 44-100-00-REV

GUDID B4474410000REV0

Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE® Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.

BONE SOLUTIONS, INC.

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• Primary Device ID: B4474410000REV0
• NIH Device Record Key: f7eb7ecc-7595-43f0-a9db-05038a36ea9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mg OSTEOREVIVE® Bone Void Filler
• Version Model Number: 10cc
• Catalog Number: 44-100-00-REV
• Company DUNS: 003506272
• Company Name: BONE SOLUTIONS, 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: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4474410000REV0 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound
• OIS: Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

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: 2022-02-10
• Device Publish Date: 2022-02-02

On-Brand Devices [Mg OSTEOREVIVE® Bone Void Filler]

• B4474415000REV0: Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE�
• B4474410000REV0: Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE�
• B4474405000REV0: Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE�