Home GUDID 09008737524845 BCI 602 Lifts (1 mm)
Primary DI 09008737524845
Brand BCI 602 Lifts (1 mm)
Company Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model 52484
Device description Bone Conduction Implant Surgical Tool
Published 2019-10-27
Public version status Update
Distribution status 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 Active Implantable Bone Conduction Hearing System
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 09008737524845 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09008737524845 09008737524845 9008737524845
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 Store the device in its sterile packaging at room temperature protected from moisture and direct heat Special Storage Condition, Specify 0 0 The product must be stored in its sterile packaging in a 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 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 09008737461522 SONNET Battery Pack Cover Micro Pro, White 46152 2026-02-26 09008737461539 SONNET Battery Pack Cover Micro Pro, Black 46153 2026-02-26 09008737583262 SoftGrip Forceps 58326 2021-04-09 09008737415808 Verifit Adapter 41580 2025-11-17 09008737002848 Surgical Claw angled 00284 2014-09-22 09008737455712 AudioLink XT Kit 45571 2025-02-26 09008737458904 AudioLink XT Core Kit 45890 2025-02-26 09008737415433 Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet 41543 41547 2024-10-15 09008737415440 Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet 41544 41548 2024-10-15 09008737416218 Insertion Electrode FLEX34 41621 2024-10-15
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