Earlens Fidelity Software, Packaged ELF003

GUDID 00850013007417

Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).

EARLENS CORPORATION

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• Primary Device ID: 00850013007417
• NIH Device Record Key: dfa666bb-f33a-42d2-8b0f-4a743f09a435
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Fidelity Software, Packaged
• Version Model Number: ELF003
• Catalog Number: ELF003
• 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: false
• 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	00850013007417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182480

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-28
• Device Publish Date: 2020-10-20

Devices Manufactured by EARLENS CORPORATION

• 08500130070192 - Earlens ELF USB: 2023-11-03 Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot n
• 00850013007387 - Impression Dispenser: 2023-06-19
• 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