GUDID 09008737047153

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

Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 09008737047153
• NIH Device Record Key: 292d3ae1-b3da-4731-9a4a-dccbecc4382b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Stimulator Template SONATATi100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008737047153 [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

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

Moist Heat or Steam Sterilization

[09008737047153]

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: 2014-09-23

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• 09008737525309 - SAMBA 2 Lo AP unit, right: 2023-06-20 Audio Processor
• 09008737525316 - SAMBA 2 Lo AP unit, left: 2023-06-20 Audio Processor