SYMFIT 5.1 Software

GUDID 09008738508981

Fitting Software

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

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• Primary Device ID: 09008738508981
• NIH Device Record Key: 9e42c7a3-592b-42e7-b7b6-18df2e542e27
• Commercial Distribution Discontinuation: 2018-11-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SYMFIT 5.1 Software
• Version Model Number: 50898
• 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: true
• 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
• 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
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008738508981 [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: 5
• Public Version Date: 2022-09-16
• Device Publish Date: 2017-06-07

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

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• 09008737525330 - SAMBA 2 BB PoM, left: 2023-07-13 Audio Processor
• 09008737525286 - SAMBA 2 Hi AP unit, right: 2023-06-20 Audio Processor
• 09008737525293 - SAMBA 2 Hi AP unit, left: 2023-06-20 Audio Processor
• 09008737525309 - SAMBA 2 Lo AP unit, right: 2023-06-20 Audio Processor
• 09008737525316 - SAMBA 2 Lo AP unit, left: 2023-06-20 Audio Processor