1091, ICS Dizcovery ShadeShift Panels 045654

GUDID 05713315010811

1091, ICS Dizcovery ShadeShift Panels

Gn Otometrics A/S

Electronystagmograph

• Primary Device ID: 05713315010811
• NIH Device Record Key: fbe74256-aa85-4b38-91eb-237688a2ac22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1091, ICS Dizcovery ShadeShift Panels
• Version Model Number: 045654
• Catalog Number: 045654
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315010811 [Primary]

FDA Product Code

• GWN: Nystagmograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-03
• Device Publish Date: 2025-02-21

Devices Manufactured by Gn Otometrics A/S

• 05713315010736 - 1091, ICS Dizcovery System: 2025-03-03 1091, ICS Dizcovery System
• 05713315010811 - 1091, ICS Dizcovery ShadeShift Panels: 2025-03-031091, ICS Dizcovery ShadeShift Panels
• 05713315010811 - 1091, ICS Dizcovery ShadeShift Panels: 2025-03-03 1091, ICS Dizcovery ShadeShift Panels
• 05713315010828 - 1091, ICS Dizcovery LCD Panels: 2025-03-03 1091, ICS Dizcovery LCD Panels
• 05713315010880 - 1091, ICS Dizcovery Universal Face Cushion (qty 40): 2025-03-03 1091, ICS Dizcovery Universal Face Cushion (qty 40)
• 05713315007415 - MADSEN Astera 2: 2024-12-20 1066 MADSEN Astera 2 with ACP, ISO Cal. Incl. HB-7 Headset, B71 BC and Wall Mounting Kit
• 05713315007439 - MADSEN Astera 2: 2024-12-20 1066 MADSEN Astera 2 w/ACP, ISO Cal. HB-7, Insert phone, DD450, B71 BC, Wall Mount Kit
• 05713315007477 - MADSEN Astera 2: 2024-12-20 1066 MADSEN Astera 2 without ACP ANSI Cal.Incl. ME70 Headset, Insert Earphone, BC-1 BC
• 05713315007521 - MADSEN Astera 2: 2024-12-20 1066 MADSEN Astera 2 with ACP, ISO Calibration Incl. ME70 Headset and BC-1 Bone conductor