SYMFIT 51529

GUDID 09008738515293

SYMFIT 7.0 Software

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

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• Primary Device ID: 09008738515293
• NIH Device Record Key: 149a9c0c-6544-4d3d-a7d7-53645e063ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYMFIT
• Version Model Number: SYMFIT 7.0 Software
• Catalog Number: 51529
• 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)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com
• Phone: +1(888)633-3527
• Email: implants.us@medel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008738515293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170009

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: 3
• Public Version Date: 2019-10-29
• Device Publish Date: 2018-08-09

On-Brand Devices [SYMFIT]

• 09008738515293: SYMFIT 7.0 Software
• 09008737531065: SYMFIT 8.0 Download package
• 09008737525859: SYMFIT 8.0 USB
• 09008737525811: SYMFIT 8.0 DVD
• 09008737525033: SYMFIT 8.0 Download