M T-Mic

GUDID 00840094499867

Medium

Advanced Bionics, LLC

Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker Cochlear implant/auditory brainstem implant sound processor speaker

• Primary Device ID: 00840094499867
• NIH Device Record Key: cef7b816-11ca-41a4-b415-7ad75d9425b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M T-Mic
• Version Model Number: CI-5837-200
• Company DUNS: 803906382
• Company Name: Advanced Bionics, LLC
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: 1(661)362-1400
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840094499867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960058

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: 2023-05-18
• Device Publish Date: 2023-05-10

On-Brand Devices [M T-Mic]

• 00840094499997: Large
• 00840094499867: Medium
• 00840094499850: Small