Amadé

GUDID 09008738504754

Audio Processor

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

Partially-implantable middle ear implant system Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor Partially-implantable middle ear implant system sound processor

• Primary Device ID: 09008738504754
• NIH Device Record Key: 1e9ec162-9f53-485d-a4e3-e75a062c3d8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amadé
• Version Model Number: Hi Silver Grey (Right)
• 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: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008738504754 [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

On-Brand Devices [Amadé]

• 09008738504785: Audio Processor
• 09008738504778: Audio Processor
• 09008738504761: Audio Processor
• 09008738504754: Audio Processor
• 09008738504747: Audio Processor
• 09008738504730: Audio Processor
• 09008738504723: Audio Processor
• 09008738504716: Audio Processor
• 09008738504709: Audio Processor
• 09008738504693: Audio Processor
• 09008738504686: Audio Processor
• 09008738504679: Audio Processor
• 09008738504662: Audio Processor
• 09008738504655: Audio Processor
• 09008738504648: Audio Processor
• 09008738504631: Audio Processor
• 09008738504624: Audio Processor
• 09008738504617: Audio Processor
• 09008738504600: Audio Processor
• 09008738504594: Audio Processor
• 09008738504587: Audio Processor
• 09008738504570: Audio Processor
• 09008738504563: Audio Processor
• 09008738504556: Audio Processor