Earlens Wireless Programmer WPUSB01

GUDID 00850013007110

Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number

EARLENS CORPORATION

Hearing device programming interface unit, line-powered 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 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: 00850013007110
• NIH Device Record Key: 2c30b491-0a68-44ca-ac13-5674d6a0e816
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Wireless Programmer
• Version Model Number: WPUSB01
• Catalog Number: WPUSB01
• 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	00850013007110 [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: 2020-05-07
• Device Publish Date: 2016-09-24

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