Earlens Wireless Updater EWU01

GUDID 08500130070000

Lot Number reflects software assembly/packaging lot number

EARLENS CORPORATION

Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit Hearing aid/implant system programming interface unit

• Primary Device ID: 08500130070000
• NIH Device Record Key: 4f8e3651-8bd7-46ab-b162-345c4b09b7b8
• Commercial Distribution Discontinuation: 2018-04-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Earlens Wireless Updater
• Version Model Number: EWU01
• Catalog Number: EWU01
• Company DUNS: 611658795
• Company Name: EARLENS CORPORATION
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08500130070000 [Primary]

FDA Product Code

• PLK: Tympanic Membrane Direct Contact Hearing Aid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-12-21
• Device Publish Date: 2017-10-20

Devices Manufactured by EARLENS CORPORATION

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• 00850013007516 - Earlens Processor, Champagne: 2023-06-19
• 00850013007523 - Earlens Processor, Silver: 2023-06-19
• 00850013007530 - Earlens Processor, Black: 2023-06-19
• 00850013007547 - Earlens Ear Tip, Left: 2023-06-19
• 00850013007554 - Earlens Ear Tip, Right: 2023-06-19
• 00850013007561 - Earlens Tympanic Lens, Left: 2023-06-19