| Primary Device ID | 00643169691964 |
| NIH Device Record Key | ebe5d26c-3657-4797-b7a5-57a60d9aa491 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 9735680 |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169691964 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-29 |
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| 00763000738501 - Aquamantys™ | 2025-04-01 AQM 6.0 BIPOLAR SEALER UNIT |
| 00763000738556 - Aquamantys™ | 2025-04-01 AQUAMANTYS 2.3 BIPOLAR SEALER UNIT |
| 00763000972318 - N/A | 2025-03-31 EMITTER 9733752R FLAT CALIBRATED |
| 00763000972325 - N/A | 2025-03-31 EMITTER 9735521R AXIEM 3 SIDE MOUNT |
| 00763000979157 - N/A | 2025-03-31 ADHESIVE PAD 9732500XOM 25PK ENT |
| 00763000582920 - N/A | 2025-03-14 TRAY 9735467 PERCUTANEOUS TRAY |
| 00643169636231 - N/A | 2025-02-25 TRIAL KIT 9734959 CLYDESDALE 12X55 MM |