| Primary Device ID | 07640178973756 |
| NIH Device Record Key | 40e1f549-5310-421f-a61c-de87c0273771 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROMEO 2 PAD INSTRUMENTATION |
| Version Model Number | SPE-IN 00 72-N |
| Catalog Number | SPE-IN 00 72-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 | 07640178973756 [Primary] |
| GEN | Forceps, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640178973756]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-31 |
| Device Publish Date | 2018-07-31 |
| 07640178975040 | Spinous process compression forceps |
| 07640178973756 | Compression forceps |
| 07640178972155 | Multiaxial Plate Inserter |
| 07640178972148 | Locking Plate Inserter |
| 07640151095048 | Spinous process compression forceps |
| 07640151092153 | Multiaxial Plate Inserter |
| 07640151092146 | Locking Plate Inserter |
| 07640151081874 | Trial Implant Size 18 |
| 07640151081867 | Trial Implant Size 16 |
| 07640139349323 | Revision screwdriver |
| 07640139349309 | Compactor |
| 07640139349293 | Compaction Base |
| 07640139349286 | Implant Holder |
| 07640139349279 | Trial Implant Size 14 |
| 07640139349262 | Trial Implant Size 12 |
| 07640139349255 | Trial Implant Size 10 |
| 07640139349248 | Trial Implant Size 08 |
| 07640178989269 | EMPTY INSTRUMENTS TRAY |