EARGO

Basic Information

• Brand Name: EARGO
• Primary DI: 00850010429113
• Version / Model: 99-0081-001
• Catalog Number: 99-0081-001
• Company Name: Eargo, Inc.
• Labeler DUNS: 079865289
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2019-10-14
• Public Version: 3
• Public Version Date: 2023-03-21
• Public Version Status: Update
• Public Device Record Key: 72795c6c-d05c-4f79-9dfe-138e211b0ba0
• Distribution End Date: 2022-09-21

Device Description

EARGO Replacement Flexi Palm, Size Regular

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
ESD	Hearing aid, air conduction	Ear, Nose, Throat	874.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60543	Hearing aid wax guard	A device intended to shield the sound outlet of a hearing aid receiver (speaker) to prevent debris (e.g., wax, sweat) from entering. It typically consists of a plastic or metal perforated cover or gauze that may be changed periodically. Attachment and removal device may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850010429113	GS1
Unit of Use	10850010429110	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]