Cochlear Magnetic battery removal tool P1316179

GUDID 09321502043748

N/A

COCHLEAR LIMITED

Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator

• Primary Device ID: 09321502043748
• NIH Device Record Key: 60b4a025-555a-4bcc-a635-976431dc7870
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear Magnetic battery removal tool
• Version Model Number: P1316179
• Catalog Number: P1316179
• 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: false
• 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	09321502043748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090720

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: 4
• Public Version Date: 2023-07-28
• Device Publish Date: 2017-11-10

Devices Manufactured by COCHLEAR LIMITED

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• 09321502036788 - Nucleus: 2023-11-03 Nucleus Smart App, (iOS)
• 09321502043205 - Nucleus: 2023-11-03 Custom Sound Suite 5.1 CD
• 09321502043212 - Nucleus: 2023-11-03 Custom Sound Suite 5.1 Download
• 09321502043236 - Nucleus: 2023-11-03 Nucleus Smart App
• 09321502044899 - Cochlear: 2023-11-03 Osia™ Fitting Software 2
• 09321502044905 - Cochlear: 2023-11-03 Osia™ Fitting Software 2
• 09321502046138 - Cochlear: 2023-11-03 Osia Smart App (iOS)