Cochlear™ Snugfit P1840430

GUDID 09321502063623

Large

COCHLEAR LIMITED

Cochlear implant/auditory brainstem implant sound processor earhook

• Primary Device ID: 09321502063623
• NIH Device Record Key: d668f9d3-b071-4464-8aa2-3568ecfc8ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear™ Snugfit
• Version Model Number: P1840430
• Catalog Number: P1840430
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502063623 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [Cochlear™ Snugfit]

• 09321502035279: Large
• 09321502035262: Medium
• 09321502035255: Small
• 09321502063623: Large
• 09321502063616: Medium
• 09321502063609: Small