FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrumentation Difra
DI: B51622092
·
Model: VIDEOSTAR II
·
Instrumentation Difra SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Instrumentation Difra
- Primary DI
- B51622092
- Version / Model
- VIDEOSTAR II
- Catalog Number
- 22092
- Company Name
- Instrumentation Difra SA
- Labeler DUNS
- 370173410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-17
- Public Version
- 1
- Public Version Date
- 2018-10-18
- Public Version Status
- New
- Public Device Record Key
- c4f78d83-ea22-4386-974d-0643082e0ecc
Device Description
The VIDEOSTAR is a digital videoscopy system. It is designed to allow qualified personnel to visualize eye reaction of the patient and record digital video. Freefield videonystagmoscope digital USB2
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HJJ | Lens, Fresnel, Flexible, Diagnostic | Ophthalmic | 886.1390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43114 | Posturography system platform | A device that is a component of a balance/mobility management system equipped with built-in sensors, transducer and/or force plates that register movement of the patient when he/she adjusts his/her centre of gravity (COG) alignment according to the doctor's instructions, or, the platform provokes destabilizing perturbations and the output of these movements are measured and recorded to the system computer. It is used, e.g., for motor control test (MCT), posture studies, balance, mobility training, and/or sense of equilibrium studies. The patient will stand on this device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B51622092 | HIBCC |
Customer Contacts
- Phone
- 260-804-4041
- [email protected]