Disposable Snap Electrodes (25 x 3 pack) 8-64-21800

GUDID 05713315008733

Gn Otometrics A/S

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode

• Primary Device ID: 05713315008733
• NIH Device Record Key: 9d007b20-c106-4886-be4e-43e533d4ac72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Snap Electrodes (25 x 3 pack)
• Version Model Number: 8-64-21800
• Catalog Number: 8-64-21800
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315008733 [Primary]

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-18
• Device Publish Date: 2022-12-14

Devices Manufactured by Gn Otometrics A/S

• 05713315011054 - Otoscan: 2024-04-23 1093,OTOSCAN Yearly – Scanner & Headset without laptop, yearly Otocloud subscription
• 05713315008726 - Disposable Snap Electrodes (3 pack): 2023-12-18
• 05713315008733 - Disposable Snap Electrodes (25 x 3 pack): 2023-12-18
• 05713315008733 - Disposable Snap Electrodes (25 x 3 pack): 2023-12-18
• 05713315010279 - Madsen A450: 2023-08-03 1081 Madsen A450
• 05713315010286 - Madsen A450: 2023-08-03 1081 Madsen A450
• 05713315010293 - Madsen A450: 2023-08-03 1081 Madsen A450
• 05713315009464 - Madsen Zodiac: 2023-07-12 1096 Zodiac PC QC
• 05713315010699 - Otoscan: 2023-05-19 1093,OTOSCAN Bundle – Scanner & Headset without laptop