Nucleus® 7 Aqua + Coil P789746

GUDID 09321502039086

6 cm (2 1/2")

COCHLEAR LIMITED

Cochlear implant system waterproof kit

• Primary Device ID: 09321502039086
• NIH Device Record Key: 6aa82a16-1b72-4acd-8c27-0493384cd623
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nucleus® 7 Aqua + Coil
• Version Model Number: P789746
• Catalog Number: P789746
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 1
• 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: 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

Device Dimensions

• Length: 6 Centimeter
• Device Size Text, specify: 0
• Length: 6 Centimeter
• Device Size Text, specify: 0
• Length: 6 Centimeter
• Device Size Text, specify: 0
• Length: 6 Centimeter
• Device Size Text, specify: 0
• Length: 6 Centimeter
• Device Size Text, specify: 0
• Length: 6 Centimeter
• Device Size Text, specify: 0
• Length: 6 Centimeter
• Device Size Text, specify: 0
• Length: 6 Centimeter
• Device Size Text, specify: 0
• Length: 6 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502039086 [Primary]

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: 2021-09-03
• Device Publish Date: 2017-06-28

On-Brand Devices [Nucleus® 7 Aqua + Coil]

• 09321502039086: 6 cm (2 1/2")
• 09321502039079: 8 cm (3")