Sentio 186323

GUDID 05712149026906

SENTIO TI IMPLANT KIT

Oticon Medical AB

Implantable vibrator bone-conduction hearing implant system

• Primary Device ID: 05712149026906
• NIH Device Record Key: 53ebb5f5-bc4a-4afb-97b0-38dac37e7c77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentio
• Version Model Number: 186323
• Catalog Number: 186323
• Company DUNS: 554563994
• Company Name: Oticon Medical AB
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05712149026906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240614

FDA Product Code

• PFO: Active Implantable Bone Conduction Hearing System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [Sentio]

• 05712149026906: SENTIO TI IMPLANT KIT
• 05712149025503: SENTIO 1 MINI, DBL
• 05712149025497: SENTIO 1 MINI, CNB
• 05712149025480: SENTIO 1 MINI, STG
• 05712149025473: SENTIO 1 MINI, SIL
• 05712149025466: SENTIO 1 MINI, TC
• 05712149025459: SENTIO 1 MINI, CBE