Mg OSTEOINJECT® Bone Void Filler 44-050-00-INJ
GUDID B4474405000INJ0
Mg OSTEOINJECT® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOINJECT® 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.
Bone matrix implant, synthetic, non-antimicrobial| Primary Device ID | B4474405000INJ0 |
| NIH Device Record Key | 908d14ec-c633-47f5-b480-1dadea71ab08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mg OSTEOINJECT® Bone Void Filler |
| Version Model Number | 5cc |
| Catalog Number | 44-050-00-INJ |
| 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 | 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B4474405000INJ0 [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 | 2022-01-19 |
| Device Publish Date | 2022-01-11 |
Devices Manufactured by BONE SOLUTIONS, INC.
| B4474410000INJ0 - Mg OSTEOINJECT® bone graft substitute | 2024-05-28 Mg OSTEOINJECT™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive |
| B4474405000REV0 - Mg OSTEOREVIVE® Bone Void Filler | 2022-02-10 Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE® Bone Void Filler Packet contai |
| B4474410000REV0 - Mg OSTEOREVIVE® Bone Void Filler | 2022-02-10 Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE® Bone Void Filler Packet contai |
| B4474415000REV0 - Mg OSTEOREVIVE® Bone Void Filler | 2022-02-10 Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOREVIVE® Bone Void Filler Packet contai |
| B4474405000INJ0 - Mg OSTEOINJECT® Bone Void Filler | 2022-01-19Mg OSTEOINJECT® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOINJECT® 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. |
| B4474405000INJ0 - Mg OSTEOINJECT® Bone Void Filler | 2022-01-19 Mg OSTEOINJECT® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOINJECT® Bone Void Filler Packet contai |
| B4477120000 - Opus Mg Set - Mixing and Delivery System | 2021-10-05 The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft |
| B4477120010 - Mixing and Delivery System | 2021-10-05 The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft |
| B4477120050 - Opus Mg Set BVF | 2021-10-05 Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesiu |
Trademark Results [Mg OSTEOINJECT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MG OSTEOINJECT 90779093 not registered Live/Pending |
Bone Solutions, Inc. 2021-06-17 |
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