N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00846430004719
• Version / Model: ER7-14C
• Company Name: ETYMOTIC RESEARCH, INC.
• Labeler DUNS: 115380859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 7a4cdc71-f4ca-474e-b6c9-879b105ea1dc

Device Description

Probe Tubes

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	874.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45241	Audiometric/hearing aid tester	An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846430004719	GS1
Unit of Use	00846430005013	GS1

Premarket Submissions

Submission Number	Supplement Number
K861113	000