Earlens Ear Tip

GUDID 08500130070222

Inductive Ear Tip w/ left & right packaged

EARLENS CORPORATION

Tympanic membrane contact hearing aid ear tip transmitter

• Primary Device ID: 08500130070222
• NIH Device Record Key: e38ba541-cda5-4d7c-8eb4-8594ae8ab25f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Ear Tip
• Version Model Number: ET01LR
• Company DUNS: 611658795
• Company Name: EARLENS CORPORATION
• Device Count: 2
• 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: 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

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08500130070222 [Primary]
GS1	08500130070314 [Unit of Use]

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 Ear Tip]

• 08500130070222: Inductive Ear Tip w/ left & right packaged
• 08500130070215: Inductive Ear Tip comes in L - Left, R - Right
• 00850013007226: Inductive Ear Tip w/ left & right packaged
• 00850013007219: Inductive Ear Tip comes in L - Left, R - Right