| Primary Device ID | B516221350 |
| NIH Device Record Key | 5ee02e8c-451d-493b-9b1b-629f82d0a0d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intrumentation Difra |
| Version Model Number | HeadStar |
| Catalog Number | 22135 |
| Company DUNS | 370173410 |
| Company Name | Instrumentation Difra SA |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B516221350 [Primary] |
| GWN | Nystagmograph |
| 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 | 2017-05-19 |
| B516320980 - Instrumentation Difra SA | 2024-02-08 The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by th |
| B516311790 - Instrumentation Difra SA | 2022-11-10 The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by th |
| B516310120 - Instrumentation Difra SA | 2022-10-06 The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow and temperatur |
| B516310130 - Instrumentation Difra SA | 2022-10-06 The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow and temperatur |
| B516223150 - Instrumentation Difra | 2021-07-06 The Ideas III is an Electronystagmography (ENG) system. Electronystagmography measures eye movements using the method of electro |
| B516174730 - Instrumentation Difra | 2020-05-26 The water caloric stimulator is a device that delivers a stream of water to the ear canal at controlled rates of flow and temper |
| B516174810 - Instrumentation Difra | 2020-05-26 The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow and temperatur |
| B516174850 - Instrumentation Difra | 2020-05-26 The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow and temperatur |