Etymotic Research

Basic Information

• Brand Name: Etymotic Research
• Primary DI: 00846430005402
• Version / Model: ER3-21-BR
• Company Name: ETYMOTIC RESEARCH, INC.
• Labeler DUNS: 115380859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-26
• Public Version: 1
• Public Version Date: 2022-02-03
• Public Version Status: New
• Public Device Record Key: 0db0303f-780b-4a54-a9d3-c26c3d8afe85

Device Description

Blue and Red ER-3 Tubes

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41234	Earphone, insert	An electroacoustic device intended to be worn in the ear to transmit sound to the ear from an external device for improved hearing or private listening. It is designed to fit either in the outer ear or is attached directly to a connecting element such as an earmould inserted in the ear canal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846430005402	GS1

Premarket Submissions

Submission Number	Supplement Number
K930003	000