| Primary Device ID | 07290016855005 |
| NIH Device Record Key | a370d7e4-813f-4aac-9ddc-2441ca8bc359 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IGI |
| Version Model Number | A-IG-0005 |
| Catalog Number | A-IG-0005 |
| Company DUNS | 532112401 |
| Company Name | IMAGE NAVIGATION LTD |
| 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 | 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 |
| Phone | +97226417748 |
| info@image-navigation.com |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016855005 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290016855005]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-02 |
| 07290016855005 | The Image-Guided Implantation system is an image-guided surgery system, designed to provide guid |
| 07290016855012 | The Image-Guided Implantation system is an image-guided surgery system, designed to provide guid |