09734

GUDID 09008737083991

Magnet Insertion Tool

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

Cochlear implant system

• Primary Device ID: 09008737083991
• NIH Device Record Key: 7012e95e-4914-4995-bbb9-3db6554bffb8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Magnet Insertion Tool
• Catalog Number: 09734
• 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: 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
• 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	09008737083991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000025

FDA Product Code

• MCM: IMPLANT, COCHLEAR

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

[09008737083991]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-19
• Device Publish Date: 2015-02-27

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• 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