Intrumentation Difra 22135

GUDID B516221350

The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR i

Instrumentation Difra SA

Electronystagmograph

• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B516221350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070670

FDA Product Code

• GWN: Nystagmograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-19

Devices Manufactured by Instrumentation Difra SA

• B516325950 - Instrumentation Difra SA: 2025-03-20 The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by th
• B516326290 - Instrumentation Difra SA: 2025-03-20 The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by th
• B516326380 - Instrumentation Difra SA: 2025-03-20 The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by th
• B516308640 - Instrumentation Difra SA: 2024-08-27 The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by th
• 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