| Primary Device ID | 07640178985018 |
| NIH Device Record Key | 0191e315-28c4-4c5c-b933-b932471568d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROMEO 2 MIS |
| Version Model Number | MIS-IN 52 13-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 | 07640178985018 [Primary] |
| HWJ | Awl |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640178985018]
Moist Heat or Steam Sterilization
[07640178985018]
Moist Heat or Steam Sterilization
[07640178985018]
Moist Heat or Steam Sterilization
[07640178985018]
Moist Heat or Steam Sterilization
[07640178985018]
Moist Heat or Steam Sterilization
[07640178985018]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2017-12-12 |
| 07640178985018 | Trocar awl |
| 07640178985001 | Trocar needle |
| 07640178984998 | Needle cap |
| 07640178984981 | Trocar Handle |
| 07640151082499 | DILATOR TUBE 3 PEEK |
| 07640151082482 | DILATOR TUBE # 2 PEEK |