Sanibel Supply A/S 8500440

GUDID 05711117232042

Interacoustics A/S

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• Primary Device ID: 05711117232042
• NIH Device Record Key: 771664b5-1009-438b-8132-1db402afc54d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sanibel Supply A/S
• Version Model Number: Gold Eartip Electrode
• Catalog Number: 8500440
• Company DUNS: 306308354
• Company Name: Interacoustics A/S
• Device Count: 20
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05711117099478 [Primary]
GS1	05711117232042 [Unit of Use]

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2023-12-05
• Device Publish Date: 2023-11-27

On-Brand Devices [Sanibel Supply A/S]

• 05711117221022: Circumaural Coupler
• 05711117228571: Accessory for Real Ear Measurement (REM), red
• 05711117228564: Accessory for Real Ear Measurement (REM), blue
• 05711117228557: Accessory for Real Ear Measurement (REM), black
• 05711117217704: Circumaural Coupler
• 05711117131086: Jumper electrode cable, 125mm
• 05711117105414: Electrode cable for TM Electrode
• 05711117019100: ETB Titan standard electrode cable kit/3pcs (BRW), 500mm
• 05711117019025: ETB standard electrode cable kit/5pcs (BRWYB), 500mm
• 05711117227413: Button electrode cable kit/5pcs (RWBYK), 500mm
• 05711117227406: Button electrode cable kit/3pcs (RWB), 500mm
• 05711117219012: Pinch clip electrode cable kit/3 pcs (WYK), 1000mm
• 05711117218145: Alligator electrode cable kit/5pcs, (RWBYK), 500mm
• 05711117218121: Alligator clip electrode cable kit/3pcs (RWB), 500 mm
• 05711117199987: Alligator clip electrode cable kit/3pcs (WYK), 500mm
• 05711117095937: Pinch clip electrode cable kit/5pcs (BRWKY)
• 05711117095920: Pinch clip electrode cable kit/3pcs (WKY)
• 05711117095913: Pinch clip electrode cable kit/3pcs (BRW)
• 05711117229066: Button electrode cable RGKW +Jumper
• 05711117229059: Button electrode cable, RWGK
• 05711117229028: Alligator clip electrode cable, RYW
• 05711117229011: Alligator clip electrode cable, RWBYK
• 05711117229004: Alligator clip electrode cable, RWBYK
• 05711117226478: Accessory for Real Ear Measurement (REM)
• 05711117094206: Accessory for Real Ear Measurement (REM), orange
• 05711117232042: Gold Eartip Electrode
• 05711117098389: Gold Eartip Electrode