| Primary Device ID | 00816986020112 |
| NIH Device Record Key | 81ed12b2-cb6d-4cb9-abcd-0864ab40893f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSTEOMATRIX+ |
| Version Model Number | 9cc |
| Catalog Number | OMP-09 |
| Company DUNS | 078450878 |
| Company Name | BIOVENTUS LLC |
| 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 | 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 |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816986020112 [Primary] |
| MQV | Filler, Bone Void, Calcium Compound |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-14 |
| Device Publish Date | 2018-12-13 |
| 00816986020129 | OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a poro |
| 00816986020112 | OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a poro |