| Primary Device ID | 03760305400079 |
| NIH Device Record Key | be91cd52-72f6-4771-9625-b14684458d40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Short Navigation Probe |
| Version Model Number | 02-0044 |
| Catalog Number | 02-0044 |
| Company DUNS | 268397609 |
| Company Name | QUANTUM SURGICAL |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
|---|---|
| GS1 | 03760305400079 [Primary] |
| JAK | System, X-Ray, Tomography, Computed |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
[03760305400079]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-19 |
| Device Publish Date | 2022-09-09 |
| 03760305400260 - EPIONE RoboKit | 2024-12-20 The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: |
| 03760305400253 - EPIONE RoboKit Plus | 2024-12-16 The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: |
| 03760305400031 - EPIONE | 2023-06-02 The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one |
| 03760305400024 - Patient Reference | 2022-09-19 The Patient Reference is an instrument of the EPIONE device used to track the patient position and motions including breathing. |
| 03760305400055 - Navigation probe | 2022-09-19 The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in t |
| 03760305400062 - Needle Guide | 2022-09-19 The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a rang |
| 03760305400079 - Short Navigation Probe | 2022-09-19The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers. |
| 03760305400079 - Short Navigation Probe | 2022-09-19 The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in t |
| 03760305400086 - EPIONE | 2022-09-19 The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one |