| Primary Device ID | 00643169843929 |
| NIH Device Record Key | f4f54c27-1097-4cac-9f7f-3cfca7e88a09 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 9735742 |
| Company DUNS | 835233107 |
| Company Name | MEDTRONIC NAVIGATION, INC. |
| 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 | 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169843929 [Primary] |
| PGW | Ear, Nose, and Throat 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 | 2019-07-12 |
| Device Publish Date | 2019-07-04 |
| 00763000738334 - AxiEM™ | 2026-02-23 POINTER 9735318 TOUCH-N-GO AXIEM PKGD |
| 00763000738341 - AxiEM™ | 2026-02-23 POINTER 9735317 TRACER AXIEM PACKAGED |
| 00763000738358 - AxiEM™ | 2026-02-23 SUCTION 9735019 MALLEABLE STD TIP 12-FR |
| 00763000738365 - AxiEM™ | 2026-02-23 SUCTION 9735018 MALLEABLE BALL TIP 9-FR |
| 00763000738372 - AxiEM™ | 2026-02-23 SUCTION 9735017 MALLEABLE ANGLE TIP 9-FR |
| 00763000738389 - AxiEM™ | 2026-02-23 SUCTION 9735016 MALLEABLE STD TIP 9-FR |
| 00763000738396 - AxiEM™ | 2026-02-23 SUCTION 9735015 MALLEABLE STD TIP 7-FR |
| 00763000738402 - AxiEM™ | 2026-02-23 PATIENT TRACKER 9735300 SKULL MOUNT PKGD |