| Primary Device ID | 00889024704213 |
| NIH Device Record Key | 1f75d074-557a-409f-8c67-4f35135b2123 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PLANNING STATION - USA |
| Version Model Number | 164063 |
| Catalog Number | ROSAS00503 |
| Company DUNS | 264502977 |
| Company Name | MEDTECH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 00889024704213 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-03 |
| Device Publish Date | 2026-02-23 |
| 00889024704213 - PLANNING STATION - USA | 2026-03-03Planning station for Rosa One 3.1.7 |
| 00889024704213 - PLANNING STATION - USA | 2026-03-03 Planning station for Rosa One 3.1.7 |
| 00889024679559 - ALLEN WRENCH 8MM | 2025-07-23 Hexagonal key for installing Leksell frame adaptor. |
| 00887868539978 - SEEG DRILL ADAPTOR 2.70MM | 2025-07-16 Seeg Drill Adaptor Ø2.70 mm instrument Rosa 3.1 (brain application) stainless steel instrument adaptor for drilling |
| 00889024671102 - PLANNING STATION - ROSA ONE - USA | 2024-05-28 Planning Station DELL 7520 Qwerty power plug B for Rosa One |
| 00887868540028 - ROBOT ARM INTERFACE | 2024-02-28 Robot Arm Interface ROSA One |
| 00889024663282 - PLANNING STATION - ROSA ONE - USA | 2024-02-28 Planning station DELL 3580 Qwerty power plug B for Rosa One 3.1.7 |
| 03760244031129 - Trnsnsl Endscp Ovoid Ø6.18mm Holder | 2023-11-06 Trnsnsl Endscp Ovoid Ø6.18mm Holder instrument Rosa 3.1 (Brain application) instrument holder for guidance of a Storz sheath 72 |
| 00887868585951 - ROSA ONE SURGICAL ASSISTANT (US) | 2023-10-24 Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B |