| Primary Device ID | 00850696006028 |
| NIH Device Record Key | 9551ec16-9523-47c6-9479-8acaa0a203ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StabiliT Bone Cement and Saturate Mixing System |
| Version Model Number | 4457 |
| Catalog Number | 4457 |
| Company DUNS | 169957607 |
| Company Name | Dfine, 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 | 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 | 00850696006028 [Primary] |
| NDN | Cement, Bone, Vertebroplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-19 |
| Device Publish Date | 2015-12-17 |
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| 00850696006011 - SpineSTAR Ablation Instrument (5|10, Long) | 2020-03-19 |
| 00850696006028 - StabiliT Bone Cement and Saturate Mixing System | 2020-03-19 |
| 00850696006028 - StabiliT Bone Cement and Saturate Mixing System | 2020-03-19 |
| 00850696006073 - StabiliT VP Fracture Kit | 2020-03-19 |
| 00850696006226 - StabiliT First Fracture Kit | 2020-03-19 |
| 00850696006233 - StabiliT First Fracture Kit | 2020-03-19 |
| 00850696006240 - STAR Tumor Ablation Kit (10|15, Short) with PowerCURVE | 2020-03-19 ala carte packaging |
| 00850696006257 - STAR Tumor Ablation Kit (5|10, Long) with PowerCURVE | 2020-03-19 ala carte packaging |