BCI Bone Conduction Implant Kit

GUDID 09008738510328

Bone Conduction Implant Kit

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

Implantable vibrator bone-conduction hearing implant system

• Primary Device ID: 09008738510328
• NIH Device Record Key: 3b56dcc6-c285-45e6-84bd-ee49b23607bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BCI Bone Conduction Implant Kit
• Version Model Number: 51032
• 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 Unsafe
• 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

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

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008738510328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170009

FDA Product Code

• PFO: Implantable Bone Conduction Hearing Aid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-09-16
• Device Publish Date: 2018-08-09

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: 2024-10-23 Cochlear Implant
• 09008737415440 - Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet: 2024-10-23 Cochlear Implant
• 09008737416218 - Insertion Electrode FLEX34: 2024-10-23 Insertion Electrode