11334-001

GUDID 09008738501463

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Partially-implantable middle ear implant system

• Primary Device ID: 09008738501463
• NIH Device Record Key: ff4b6223-290b-4ffc-ba24-a577e1ac741b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AP Adapter
• Catalog Number: 11334-001
• Company DUNS: 300764032
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008738501463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990052

FDA Product Code

• MPV: Implant, Hearing, Active, Middle Ear, Partially Implanted

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: 2019-04-03
• Device Publish Date: 2014-09-22

Devices Manufactured by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

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• 09008737371371 - ANTS Electrode: 2024-11-01 Diagnostic Electrode
• 09008737405557 - Insertion Probe L: 2024-11-01 Single-Use Surgical Tool
• 09008737415433 - Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet: 2024-10-23 Cochlear Implant
• 09008737415440 - Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet: 2024-10-23 Cochlear Implant
• 09008737416218 - Insertion Electrode FLEX34: 2024-10-23 Insertion Electrode