Cochlear Surgical Instrument Upgrade Kit Z145225

GUDID 09321502014557

COCHLEAR LIMITED

ENT surgical procedure kit, non-medicated, reusable

• Primary Device ID: 09321502014557
• NIH Device Record Key: 76ecbdbe-0c88-4f73-be3e-8326869c845d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear Surgical Instrument Upgrade Kit
• Version Model Number: Z145225
• Catalog Number: Z145225
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502014557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970051

FDA Product Code

• MCM: Implant, cochlear

Sterilization

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

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

[09321502014557]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-15
• Device Publish Date: 2024-11-07

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• 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