Osia OSI300 Implant P1772248

GUDID 09321502070676

COCHLEAR LIMITED

Implantable vibrator bone-conduction hearing implant system

• Primary Device ID: 09321502070676
• NIH Device Record Key: ff4cee11-868f-44c9-90b7-3398a28457f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osia OSI300 Implant
• Version Model Number: P1772248
• Catalog Number: P1772248
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 1
• DM Exempt: false
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502070676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231204

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: 2023-09-25
• Device Publish Date: 2023-09-15

Devices Manufactured by COCHLEAR LIMITED

• 09321502002776 - Nucleus: 2025-03-07 CI24RE Series Non-Magnetic Plug
• 09321502002790 - Nucleus: 2025-03-07 Cochlear Nucleus Depth Gauge (Straight)
• 09321502013369 - Nucleus: 2025-03-07 Cochlear Nucleus CI500 Series Non-Sterile Silicone Implant Template
• 09321502018395 - Nucleus: 2025-03-07 CI500 Series Non-Magnetic Plug
• 09321502024655 - Nucleus: 2025-03-07 Cochlear Nucleus LiteWear Case
• 09321502046152 - Cochlear: 2025-03-07 Cochlear Osia OSI200 Implant
• 09321502026895 - Nucleus: 2025-02-18 NUCLEUS AQUA COIL, 6CM
• 09321502014557 - Cochlear Surgical Instrument Upgrade Kit: 2024-11-15