Soft Tipped Medial Mixing Tip(Blue) IDT03

GUDID 00850013007424

EARLENS CORPORATION

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• Primary Device ID: 00850013007424
• NIH Device Record Key: f456c019-d78d-4f7b-8358-bc63e8416de8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soft Tipped Medial Mixing Tip(Blue)
• Version Model Number: IDT03
• Catalog Number: IDT03
• Company DUNS: 611658795
• Company Name: EARLENS CORPORATION
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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	00850013007424 [Primary]
GS1	00850013007455 [Unit of Use]

FDA Product Code

• LDG: Kit, Earmold, Impression

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: 2021-06-30
• Device Publish Date: 2021-06-22

Devices Manufactured by EARLENS CORPORATION

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• 00850013007387 - Impression Dispenser: 2023-06-19
• 00850013007516 - Earlens Processor, Champagne: 2023-06-19
• 00850013007523 - Earlens Processor, Silver: 2023-06-19
• 00850013007530 - Earlens Processor, Black: 2023-06-19
• 00850013007547 - Earlens Ear Tip, Left: 2023-06-19
• 00850013007554 - Earlens Ear Tip, Right: 2023-06-19
• 00850013007561 - Earlens Tympanic Lens, Left: 2023-06-19