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

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09008737353254ADHEAR Headband, pink353252018-06-27
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09008737396091ADHEAR Headband, blue, bilateral396092019-11-08
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09008737461386SONNET Battery Pack Cover Standard Pro, Ebony461382026-02-26
09008737461393SONNET Battery Pack Cover Standard Pro, Nordic Gray461392026-02-26
09008737461409SONNET Battery Pack Cover Standard Pro, Beige461402026-02-26
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09008737461508SONNET Battery Pack Cover Micro Pro, Nordic Gray461502026-02-26
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