| Primary Device ID | 00855195006616 |
| NIH Device Record Key | 1f4af750-4cb9-41c3-83fb-cf5dc3b9c6f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spectrum GV |
| Version Model Number | SPECTRUM40 |
| Company DUNS | 079596704 |
| Company Name | OSTEOREMEDIES, 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855195006616 [Primary] |
| MBB | Bone Cement, Antibiotic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-21 |
| Device Publish Date | 2018-11-20 |
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