Cochlear™ Sterile Non-Magnetic Plug P1620901

GUDID 09321502046527

COCHLEAR LIMITED

Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet

• Primary Device ID: 09321502046527
• NIH Device Record Key: ca480776-efba-4663-af08-35e6cd021030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear™ Sterile Non-Magnetic Plug
• Version Model Number: P1620901
• Catalog Number: P1620901
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502046527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191921

FDA Product Code

• PFO: Active implantable bone conduction hearing system

Sterilization

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

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

[09321502046527]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-17
• Device Publish Date: 2021-03-09

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)