Earlens Contact Hearing Solution, Monaural, Left IK01L

GUDID 00850013007264

Kit containing Left Ear Tip & Processor Assembly, Left Tympanic Lens, Charger. Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black,

EARLENS CORPORATION

Tympanic membrane contact hearing aid

• Primary Device ID: 00850013007264
• NIH Device Record Key: c39cdca4-4d0e-4f63-a494-46e03f9566e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Contact Hearing Solution, Monaural, Left
• Version Model Number: IK01L
• Catalog Number: IK01L
• Company DUNS: 611658795
• Company Name: EARLENS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013007264 [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 Contact Hearing Solution, Monaural, Left]

• 08500130070260: Kit containing Left Ear Tip & Processor Assembly, Left Tympanic Lens, Charger. Processor comes
• 00850013007264: Kit containing Left Ear Tip & Processor Assembly, Left Tympanic Lens, Charger. Processor comes