Earlens Wireless Updater

Basic Information

• Brand Name: Earlens Wireless Updater
• Primary DI: 08500130070000
• Version / Model: EWU01
• Catalog Number: EWU01
• Company Name: EARLENS CORPORATION
• Labeler DUNS: 611658795
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-20
• Public Version: 7
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 4f8e3651-8bd7-46ab-b162-345c4b09b7b8
• Distribution End Date: 2018-04-10

Device Description

Lot Number reflects software assembly/packaging lot number

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: No
• PM Exempt: No
• 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
PLK	Tympanic Membrane Direct Contact Hearing Aid	Ear, Nose, Throat	874.3315	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61462	Hearing aid/implant system programming interface unit	A portable, electrically-powered device intended to facilitate the wireless or wired connection of a hearing aid or implant system component (e.g., sound processor) to a computer for programming of the hearing device with patient-specific settings and sometimes assessment. It typically consists of a small unit attached to the hearing device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08500130070000	GS1