Etymotic

GUDID 00846430005563

18mm horn foam eartips 24/pk

ETYMOTIC RESEARCH, INC.

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• Primary Device ID: 00846430005563
• NIH Device Record Key: 5b5e726a-f8ad-488c-9420-cfea88290657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etymotic
• Version Model Number: ER13-14C
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846430005563 [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: 2022-11-18
• Device Publish Date: 2022-11-10

On-Brand Devices [Etymotic]

• 00846430004016: Replacement Filters 6pk-orange
• 00846430005396: ER3-60 Gold Eartip Electrode Cable with Snap Connector
• 00846430005389: Shirt Clip for ER36 Micro-Probe (50 pcs per bag) bulk
• 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