FDA.reportPublic FDA data

BCI Sizer Kit

Primary DI
09008738512537
Brand
BCI Sizer Kit
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
51253
Device description
Bone Conduction Implant Template Kit
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
09008738512537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008738512537090087385125379008738512537

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

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 Sizer Kit shall be stored in its 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09008737583262SoftGrip Forceps583262021-04-09
09008737415808Verifit Adapter415802025-11-17
09008737002848Surgical Claw angled002842014-09-22
09008737455712AudioLink XT Kit455712025-02-26
09008737458904AudioLink XT Core Kit458902025-02-26
09008737415433Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet41543415472024-10-15
09008737415440Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet41544415482024-10-15
09008737416218Insertion Electrode FLEX34416212024-10-15
09008737304928SONNET FM Battery Pack Cover anthracite304922015-02-28
09008737308339SONNET FM Battery Pack Cover ebony308332015-02-28
09008737308346SONNET FM Battery Pack Cover black308342015-02-28
09008737308353SONNET FM Battery Pack Cover white308352015-02-28
09008737308360SONNET FM Battery Pack Cover beige308362015-02-28
09008737308377SONNET FM Battery Pack Cover nordic grey308372015-02-28
09008737049997OPUS 2 FM Extension Kit anthracite049992022-09-15
09008737050009OPUS 2 Children's Extension Kit anthracite050002022-09-15
09008737050030OPUS 2 FM Extension Kit beige050032022-09-15
09008737050047OPUS 2 Children's Extension Kit beige050042022-09-15
09008737050078OPUS 2 FM Extension Kit red050072022-09-15
09008737050085OPUS 2 Children's Extension Kit red050082022-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712149025459SentioOticon Medical ABPFO2024-07-22
05712149025466SentioOticon Medical ABPFO2024-07-22
05712149025473SentioOticon Medical ABPFO2024-07-22
05712149025480SentioOticon Medical ABPFO2024-07-22
05712149025497SentioOticon Medical ABPFO2024-07-22
05712149025503SentioOticon Medical ABPFO2024-07-22
05712149026906SentioOticon Medical ABPFO2024-07-22
09321502074131OSIA FITTING SOFTWARE 2 CDCochlear Americas CorporationPFO2024-01-03
09321502070409Osia 2(I) Sound Processor kitCOCHLEAR LIMITEDPFO2023-09-15
09321502070676Osia OSI300 ImplantCOCHLEAR LIMITEDPFO2023-09-15
09321502070683Cochlear™ Magnet CassetteCOCHLEAR LIMITEDPFO2023-09-15
09321502070959Osia 2(I) SP Magnet strength 1(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070966Osia 2 (I) SP Magnet strength 2(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070973Osia 2(I) SP Magnet strength 3(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070980Osia 2(I) SP Magnet strength 4(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070997Osia 2(I) SP Magnet (I) ToolCOCHLEAR LIMITEDPFO2023-09-15
09008737525323SAMBA 2 BB PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2023-07-05
09008737525330SAMBA 2 BB PoM, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2023-07-05
09008737532925SAMBA 2 GO w/o manualsMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2022-11-16
09321502065924Cochlear™ MRI KitCOCHLEAR LIMITEDPFO2022-08-10
09321502046527Cochlear™ Sterile Non-Magnetic PlugCOCHLEAR LIMITEDPFO2021-03-09
09321502046534Cochlear™ Sterile Replacement MagnetCOCHLEAR LIMITEDPFO2021-03-09
09008737520472SAMBA 2 Remote (Android)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525033SYMFIT 8.0 DownloadMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525071SAMBA 2 GOMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525262SAMBA 2 BB AP Unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525279SAMBA 2 BB AP Unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525811SYMFIT 8.0 DVDMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525859SYMFIT 8.0 USBMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737526030SAMBA 2 Remote (iOS)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08