| Primary Device ID | 07640178981843 |
| NIH Device Record Key | 13773c34-d218-4e68-adac-886aba5edab4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROMEO 2 INSTRUMENTATION |
| Version Model Number | ELL-IN 00 46-N |
| Catalog Number | ELL-IN 00 46-N |
| Company DUNS | 483016148 |
| Company Name | SpineArt SA |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640178981843 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640178981843]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2018-12-20 |
| 07640178982253 | TAP Ø7 x 30 |
| 07640178982055 | FINAL TIGHTENER 13 HEXAGON |
| 07640178982048 | FINAL TIGHTENER 13 HEXALOBE |
| 07640178982024 | TAP Ø6 x 30 |
| 07640178982017 | TAP Ø5 x 30 |
| 07640178981959 | PEDICLE PROBE LENKE STRAIGHT |
| 07640178981942 | PEDICLE PROBE LENKE CURVED |
| 07640178981935 | PEDICLE PROBE STRAIGHT |
| 07640178981928 | DEROTATION HANDLE |
| 07640178981850 | DRILL Ø3.2 |
| 07640178981843 | ADJUSTABLE DRILL GUIDE |
| 07640178981836 | DRILL GUIDE |
| 07640178981829 | ROD TRIAL LONG |
| 07640178981812 | ROD TRIAL SHORT |
| 07640178981805 | REAMER |
| 07640178981799 | SCREWDRIVER SHAFT PS |
| 07640178981744 | FINE PITCH RATCHETING T-HANDLE |
| 07640178981737 | FINE PITCH STRAIGHT RATCHETING HANDLE |
| 07640178980822 | SETSCREW HOLDER H |
| 07640178980815 | RIBAC L |
| 07640178980808 | RIBAC R |
| 07640178980464 | SCREWDRIVER SHAFT PS STRAIGHT |
| 07640178980136 | TAP Ø 4 X 30 |
| 07640178980129 | TAP Ø 4.5 X 30 |
| 07640178980112 | TAP Ø 6.5 X 30 |
| 07640178980105 | TAP Ø 5.5 X 30 |
| 07640178979901 | 4.0 TIGHTENER |
| 07640178975453 | TAP Ø7 x 30 |
| 07640178975446 | TAP Ø6 x 30 |
| 07640178975439 | TAP Ø5 x 30 |
| 07640178975057 | COUNTER TORQUE ADAPTED FOR BDYN IMPLANT |
| 07640178975033 | CLIPPING TUBE OPEN |
| 07640178975026 | CLIPPING TUBE |
| 07640178975019 | TROCAR 3 IN 1- LONG TIP AWL |
| 07640178974999 | QR REDUCER LINK - BRIDGE II |
| 07640178974845 | QR REDUCER Ti |
| 07640178973862 | SETSCREW HOLDER |
| 07640178973855 | FINAL TIGHTENER |
| 07640178973848 | SETSCREW TIGHTENER |
| 07640178973039 | COUNTER TORQUE 90° |
| 07640178972896 | COUNTER TORQUE |
| 07640178972889 | DRILL Ø 3.2 MM |
| 07640178972803 | RIBAC |
| 07640178972797 | QR REDUCER LINK - BRIDGE |
| 07640178972780 | QR REDUCER LINK |
| 07640178972773 | QR REDUCER |
| 07640178972766 | SETSCREW TUBE H |
| 07640178972759 | DUAL CALIPER |
| 07640178972742 | SETSCREW HOLDER H |
| 07640178972575 | VARIABLE ENDTIP ROD HOLDER |