Instrumentation Difra
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Instrumentation Difra
- Primary DI
- B516223150
- Version / Model
- Ideas III
- Catalog Number
- 22315
- Company Name
- Instrumentation Difra SA
- Labeler DUNS
- 370173410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-28
- Public Version
- 1
- Public Version Date
- 2021-07-06
- Public Version Status
- New
- Public Device Record Key
- 67fba97f-29f2-40ef-a2db-3bbe7607a71e
Device Description
The Ideas III is an Electronystagmography (ENG) system. Electronystagmography measures eye movements using the method of electro-oculography (EOG). In this method, skinmounted electrodes measure changes in potentials across the eyeball due to movement of the eye in its socket. The corneal retinal potential is the source of the measured voltage. Those movements are recorded and transmitted to a computer. The eye movement is analyzed by the software.Ideas III is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests). Ideas III is able to record horizontal and vertical movements simultaneously on both eyes or on one eye only.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWN | Nystagmograph | Neurology | 882.1460 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11479 | Electronystagmograph | A graphic recorder used for detecting the electrical potential caused by eye movements. This recorder includes an electrode for each eye and one on the forehead (multichannel recording) for measuring the potential from both eyes simultaneously, or repositioning of the electrodes before each test for single channel recording. Electronystagmographs are used for detecting multiple sclerosis, vestibular dysfunctions, the presence of drugs and other specific disorders characterized by involuntary eye movement (nystagmus). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B516223150 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070670 | 000 |