Etymotic

GUDID 00846430005495

Hook-and-loop Neck Strap for ER3C

ETYMOTIC RESEARCH, INC.

Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert Earphone, insert

• Primary Device ID: 00846430005495
• NIH Device Record Key: 636f4785-cb1e-46eb-9b7e-d2e07fd29f32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etymotic
• Version Model Number: ER3C-33
• Company DUNS: 115380859
• Company Name: ETYMOTIC RESEARCH, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com
• Phone: +1 847-228-0006
• Email: customer-service@etymotic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846430005495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930003

FDA Product Code

• EWO: Audiometer

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: 2022-11-22
• Device Publish Date: 2022-11-14

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• 00846430005563: 18mm horn foam eartips 24/pk
• 00846430005495: Hook-and-loop Neck Strap for ER3C
• 00846430005471: Cable Replacement for ER3C ABR – 7 ft.
• 00846430005464: Cable Replacement for ER3C ABR – 20 ft.
• 00846430005457: ER3C-300 Replacement Cable
• 00846430005617: SAMPLE Foam eartips - jumbo 500/pkg
• 00846430005600: SAMPLE Foam eartips - baby 500/pkg