Cochlear™ Headworn Adaptor Z544861

GUDID 09321502035170

Left

COCHLEAR LIMITED

Cochlear implant system sound processor earhook Cochlear implant system sound processor earhook Cochlear implant system sound processor earhook Cochlear implant system sound processor earhook Cochlear implant system sound processor earhook Cochlear implant system sound processor earhook Cochlear implant system sound processor earhook Cochlear implant system sound processor earhook Cochlear implant system sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook Cochlear implant/auditory brainstem implant sound processor earhook

• Primary Device ID: 09321502035170
• NIH Device Record Key: 0e7c0c98-1345-4498-9f53-5c001cbd6024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear™ Headworn Adaptor
• Version Model Number: Z544861
• Catalog Number: Z544861
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502035170 [Primary]
GS1	09321502042178 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-08-30
• Device Publish Date: 2017-07-07

On-Brand Devices [Cochlear™ Headworn Adaptor]

• 09321502035187: Right
• 09321502035170: Left