Nucleus® SmartNav P11799437

GUDID 09321502065917

COCHLEAR LIMITED

Cochlear implant intraoperative electrophysiological analysis software

• Primary Device ID: 09321502065917
• NIH Device Record Key: 1cd073f7-442e-4be3-a848-b816642d77a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nucleus® SmartNav
• Version Model Number: V2
• Catalog Number: P11799437
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• 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: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502065917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970051
• Premarket Approval: P970051

FDA Product Code

• MCM: Implant, cochlear

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: 2022-10-27
• Device Publish Date: 2022-10-19

Devices Manufactured by COCHLEAR LIMITED

• 09321502053082 - Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Straight electrode: 2025-07-15 Cochlear Implant
• 09321502053099 - Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode: 2025-07-15 Cochlear Implant
• 09321502053105 - Cochlear™ Nucleus® Nexa™ cochlear implant with Slim 20 electrode: 2025-07-15 Cochlear Implant
• 09321502053662 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil: 2025-07-15 Hearing Implant Accessory
• 09321502053679 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil: 2025-07-15 Hearing Implant Accessory
• 09321502053686 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil: 2025-07-15 Hearing Implant Accessory
• 09321502053693 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil: 2025-07-15 Hearing Implant Accessory
• 09321502053709 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil: 2025-07-15 Hearing Implant Accessory