Earlens Processor & Ear Tip

GUDID 08500130070239

Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, Ear Tip comes in L - Left, R - Right

EARLENS CORPORATION

Tympanic membrane contact hearing aid sound processor

• Primary Device ID: 08500130070239
• NIH Device Record Key: 25859da4-bc42-46f1-be82-e2f3a9b9abd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Processor & Ear Tip
• Version Model Number: PET01X
• 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: 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	08500130070239 [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: 2019-05-14
• Device Publish Date: 2019-05-06

On-Brand Devices [Earlens Processor & Ear Tip]

• 08500130070239: Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in differ
• 00850013007233: Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in differ