| Primary Device ID | B057U3010010 |
| NIH Device Record Key | c180edc1-4adb-49de-8dbd-ae6d44000050 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Field generator planar |
| Version Model Number | 1.0 |
| Catalog Number | U3 010 01 |
| Company DUNS | 341702266 |
| Company Name | Scopis GmbH |
| 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 | 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 |
|---|---|
| HIBCC | B057U3010010 [Primary] |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-01-04 |
| B057U9020010 - Patient tracker tabs (PU 100) | 2019-10-23 Patient tracker tabs are circular, medical grade, double-sided adhesive tape. They serve to attach the navigation references pro |
| B057U1017010 - Instrument clamp 2-6 mm | 2018-10-22 The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To |
| B057U1017020 - Instrument clamp forceps | 2018-10-22 The Instrument clamp forceps is part of a clamp set that provides mounting of instrument trackers to conventional instruments. T |
| B057U1017030 - Instrument clamp 6-10 mm | 2018-10-22 The Instrument clamp 6-10 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. T |
| B057U1017050 - Instrument clamp 10-16 mm | 2018-10-22 The Instrument clamp 10-16 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. |
| B057U4003260170 - NOVA AR | 2018-07-31 The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of ta |
| B057U1029010 - Precision Pointer EM | 2018-03-29 The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to naviga |
| B057U1029030 - Registration pointer EM-D | 2018-03-29 The Registration Pointer EM-D is an electromagnetically tracked instrument with a rounded, blunt tip that is used to register th |