| Primary Device ID | 00810152100141 |
| NIH Device Record Key | e6cbaf93-c9ad-4b08-803f-296c3f11e8f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FUSIO SI Allograft System |
| Version Model Number | BI0014 |
| Catalog Number | BI0014 |
| Company DUNS | 124592779 |
| Company Name | PROMETHEAN RESTORATIVE LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810152100141 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
[00810152100141]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-28 |
| Device Publish Date | 2024-10-18 |
| 00810152100189 | 5MM DRILL |
| 00810152100172 | DILATOR |
| 00810152100165 | TRIAL / GRAFT PUSHER |
| 00810152100141 | Instrument Tray Lid |
| 00810152100134 | Instrument Tray |
| 00810152100127 | Guidewire, DIA 2.8mm X 250mm |
| 00810152100110 | Guidewire, DIA 3.2mm X 250mm |
| 00810152100103 | Jacob's Chuck Handle |
| 00810152100097 | Tuning Fork |
| 00810152100080 | Broach |
| 00810152100073 | Graft Pusher |
| 00810152100066 | Dilator |
| 00810152100059 | Guide Tube |
| 00810152100042 | 6MM DRILL |
| 00810152100035 | ALLOGRAFT TRIAL, 9MM |
| 00810152100028 | ALLOGRAFT INSERTER INNER SHAFT |
| 00810152100004 | ALLOGRAFT INSERTER |