FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PFOImplantable Bone Conduction Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFOActive Implantable Bone Conduction Hearing SystemEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170009000BonebridgeMed-El Elektromedizinische Geraete GmbH2018-07-20PFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008738512544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008738512544090087385125449008738512544

GMDN Terms#

Term, Definition table
TermDefinition
Implantable vibrator bone-conduction hearing implant systemA 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
TypeValueUnit
Height0.04Inch
Height1Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify00The BCI Lifts shall be stored in their sterile packaging in a cool and dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)633-3527implants.us@medel.com

Regulatory Flags#

DUNS number
300764032
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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