Insertion Electrode FLEX34

GUDID 09008737416218

Insertion Electrode

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

Cochlear implant system

• Primary Device ID: 09008737416218
• NIH Device Record Key: c8e16333-5502-4641-b5bc-81fc19f6cc56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insertion Electrode FLEX34
• Version Model Number: 41621
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008737416218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000025

FDA Product Code

• MCM: Implant, Cochlear

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-23
• Device Publish Date: 2024-10-15

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