Cochlear™ Safety Line (Short Double Loop) P789715

GUDID 09321502035996

Brown

COCHLEAR LIMITED

Cochlear implant system sound processor earhook

• Primary Device ID: 09321502035996
• NIH Device Record Key: ef07c117-4f09-462e-9220-3b4dcca998d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear™ Safety Line (Short Double Loop)
• Version Model Number: P789715
• Catalog Number: P789715
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502035996 [Primary]
GS1	09321502040563 [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: 2021-08-27
• Device Publish Date: 2016-10-13

On-Brand Devices [Cochlear™ Safety Line (Short Double Loop)]

• 09321502036344: N/A
• 09321502036009: White
• 09321502035996: Brown
• 09321502035989: Black