Home GUDID 09008738512544 BCI Lifts (1 mm)
Primary DI 09008738512544
Brand BCI Lifts (1 mm)
Company Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model 51254
Device description Bone Conduction Implant Surgical Tool
Published 2018-08-09
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name PFO Implantable Bone Conduction Hearing Aid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PFO Active Implantable Bone Conduction Hearing System Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09008738512544 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09008738512544 09008738512544 9008738512544
GMDN Terms# Term, Definition table Term Definition Implantable vibrator bone-conduction hearing implant system A battery-powered, electromechanical device assembly intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear via an implanted vibrator. It typically consists of an externally worn microphone/sound processor, and a sterile vibrator assembly which is implanted in the skull (e.g., mastoid or temporal bone). The microphone receives sound waves and converts them into electrical signals (radio waves) which are sent to the vibrator wirelessly through the skin (transcutaneously) for the transmission of vibrations to the inner ear via bone conduction. It is used to treat conductive and mixed hearing loss.
Device Sizes# Type, Value, Unit table Type Value Unit Height 0.04 Inch Height 1 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -20 Degrees Celsius 60 Degrees Celsius Handling Environment Temperature -4 Degrees Fahrenheit 140 Degrees Fahrenheit Special Storage Condition, Specify 0 0 The BCI Lifts shall be stored in their sterile packaging in a cool and dry place.
Regulatory Flags# DUNS number 300764032 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09008737346898 ADHEAR Adhesive Adapters, beige, 15 pcs. 34689 2018-06-27 09008737346904 ADHEAR Adhesive Adapters, brown, 15 pcs. 34690 2018-06-27 09008737346911 ADHEAR Headband, black 34691 2018-06-27 09008737353247 ADHEAR Headband, beige 35324 2018-06-27 09008737353254 ADHEAR Headband, pink 35325 2018-06-27 09008737353261 ADHEAR Headband, blue 35326 2018-06-27 09008737396060 ADHEAR Headband, black, bilateral 39606 2019-11-08 09008737396077 ADHEAR Headband, beige, bilateral 39607 2019-11-08 09008737396084 ADHEAR Headband, pink, bilateral 39608 2019-11-08 09008737396091 ADHEAR Headband, blue, bilateral 39609 2019-11-08 09008737461379 SONNET Battery Pack Cover Standard Pro, Anthracite 46137 2026-02-26 09008737461386 SONNET Battery Pack Cover Standard Pro, Ebony 46138 2026-02-26 09008737461393 SONNET Battery Pack Cover Standard Pro, Nordic Gray 46139 2026-02-26 09008737461409 SONNET Battery Pack Cover Standard Pro, Beige 46140 2026-02-26 09008737461416 SONNET Battery Pack Cover Standard Pro, White 46141 2026-02-26 09008737461423 SONNET Battery Pack Cover Standard Pro, Black 46142 2026-02-26 09008737461485 SONNET Battery Pack Cover Micro Pro, Anthracite 46148 2026-02-26 09008737461492 SONNET Battery Pack Cover Micro Pro, Ebony 46149 2026-02-26 09008737461508 SONNET Battery Pack Cover Micro Pro, Nordic Gray 46150 2026-02-26 09008737461515 SONNET Battery Pack Cover Micro Pro, Beige 46151 2026-02-26
Other Devices Sharing Product Codes# 
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