Cochlear™ Microphone Cover P1878197

GUDID 09321502065450

Silver

COCHLEAR LIMITED

Cochlear implant/auditory brainstem implant coil cover/spacer

• Primary Device ID: 09321502065450
• NIH Device Record Key: 9abc9e77-8c56-48b7-8dea-c147a3c9740c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear™ Microphone Cover
• Version Model Number: P1878197
• Catalog Number: P1878197
• 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: true
• 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	09321502065450 [Unit of Use]
GS1	09321502066860 [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™ Microphone Cover]

• 09321502035378: Black
• 09321502035361: White
• 09321502035354: Brown
• 09321502035347: Grey
• 09321502035330: Sand
• 09321502065450: Silver
• 09321502065443: White
• 09321502065429: Sand
• 09321502065436: Grey
• 09321502065412: Brown
• 09321502065405: Black