Primary Device ID | 07640178975033 |
NIH Device Record Key | f8e2063b-bbcc-48da-8eb8-7532364d0117 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ROMEO 2 INSTRUMENTATION |
Version Model Number | SPE-IN 00 75-N |
Catalog Number | SPE-IN 00 75-N |
Company DUNS | 483016148 |
Company Name | SpineArt SA |
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 | 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 | 07640178975033 [Primary] |
KWP | Appliance, Fixation, Spinal Interlaminal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
[07640178975033]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-01-21 |
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 |