TransEar none

GUDID 00810323003806

bone conduction hearing aid -

EAR TECHNOLOGY CORPORATION

Bone vibrator

• Primary Device ID: 00810323003806
• NIH Device Record Key: 4a7bd828-8373-45ac-afb4-462868bd7be1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransEar
• Version Model Number: TE380
• Catalog Number: none
• Company DUNS: 023930584
• Company Name: EAR TECHNOLOGY 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810323003806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050653

FDA Product Code

• LXB: Hearing Aid, Bone Conduction

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: 2020-08-05
• Device Publish Date: 2016-10-06

On-Brand Devices [TransEar]

• 08103230003802: bone conduction hearing aid -
• 00810323003806: bone conduction hearing aid -