Earlens Fitting Software, USB ELF002

GUDID 00850013007295

Inductive 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: 00850013007295
• NIH Device Record Key: a802729f-be1a-4adf-b0c0-0b081ea26485
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Fitting Software, USB
• Version Model Number: ELF002
• Catalog Number: ELF002
• 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	00850013007295 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-07
• Device Publish Date: 2019-05-06

On-Brand Devices [Earlens Fitting Software, USB]

• 08500130070291: Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Ver
• 00850013007295: Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Ver