Earlens ELF USB ELF001

GUDID 00850013007042

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

EARLENS CORPORATION

Audiometric/hearing device software

• Primary Device ID: 00850013007042
• NIH Device Record Key: 7274bf17-318c-4ede-a0e5-52af050bf458
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens ELF USB
• Version Model Number: ELF001
• Catalog Number: ELF001
• 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	00850013007042 [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: 7
• Public Version Date: 2020-05-07
• Device Publish Date: 2016-09-24

On-Brand Devices [Earlens ELF USB]

• 00850013007042: Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in
• 08500130070192: Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version L