Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet 41547

GUDID 09008737415433

Cochlear Implant

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

Cochlear implant system

• Primary Device ID: 09008737415433
• NIH Device Record Key: c36dc149-b821-4b75-9c4e-dec61fb9daeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet
• Version Model Number: 41543
• Catalog Number: 41547
• 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: MR Conditional
• 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	09008737415433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000025

FDA Product Code

• PGQ: Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

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

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

• 09008737335632 - Insertion Probe: 2024-11-01 Single-Use Surgical Tool
• 09008737369736 - ANTS Connector Cable: 2024-11-01 Cable
• 09008737370053 - Stimulator Box: 2024-11-01 Hardware Interface System
• 09008737371371 - ANTS Electrode: 2024-11-01 Diagnostic Electrode
• 09008737405557 - Insertion Probe L: 2024-11-01 Single-Use Surgical Tool
• 09008737415433 - Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet: 2024-10-23Cochlear Implant
• 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