Bonebridge 52484

GUDID 09008737524845

BCI 602 Lifts (1 mm)

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

Implantable vibrator bone-conduction hearing implant system

• Primary Device ID: 09008737524845
• NIH Device Record Key: dddf37d0-7733-4676-8227-08301e090c1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonebridge
• Version Model Number: 52484
• Catalog Number: 52484
• 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: true
• Serial Number: false
• 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: 1-888-633-3524
• 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 Dimensions

• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter
• Height: 0.04 Inch
• Height: 1 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 *The product must be stored in its sterile packaging in a 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 the device in its sterile packaging at room temperature protected from moisture and direct heat
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in its sterile packaging at room temperature protected from moisture and direct heat
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in its sterile packaging at room temperature protected from moisture and direct heat
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in its sterile packaging at room temperature protected from moisture and direct heat
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in its sterile packaging at room temperature protected from moisture and direct heat
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in its sterile packaging at room temperature protected from moisture and direct heat
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in its sterile packaging at room temperature protected from moisture and direct heat
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in its sterile packaging at room temperature protected from moisture and direct heat
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in its sterile packaging at room temperature protected from moisture and direct heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008737524845 [Primary]

FDA Product Code

• PFO: Active Implantable Bone Conduction Hearing System

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: 2019-11-04
• Device Publish Date: 2019-10-27

On-Brand Devices [Bonebridge]

• 09008738521805: BCI Bone Conduction Implant Kit
• 09008737524852: BCI 602 Sizer Kit
• 09008737524845: BCI 602 Lifts (1 mm)
• 09008737524838: BCI 602 Kit which contains the BCI 602 Implant Kit and the BCI 602 Sizer Kit
• 09008737522605: Surgical Screwdriver SD 2
• 09008738517846: SAMBA BB R, AP Unit
• 09008738517839: SAMBA BB L, AP Unit
• 09008738515606: Samba BB audio processor (Right)
• 09008738515590: Samba BB audio processor (Left)