BCI Lifts (2 mm & 3 mm)

GUDID 09008738512551

Bone Conduction Implant Surgical Tool

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

Implantable vibrator bone-conduction hearing implant system

• Primary Device ID: 09008738512551
• NIH Device Record Key: fe3f4685-3160-4e94-bbdb-7550df2cb3cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BCI Lifts (2 mm & 3 mm)
• Version Model Number: 51255
• 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)633-3527
• 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

Device Dimensions

• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch
• Height: 0.12 Inch
• Height: 2 Millimeter
• Height: 3 Millimeter
• Height: 0.08 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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 *The BCI Lifts shall be stored in their sterile packaging 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	09008738512551 [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

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