BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Magnet Replacement Kit

    DI: 09008737096939 · Model: 09693 · Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Magnet Replacement Kit
    Primary DI
    09008737096939
    Version / Model
    09693
    Company Name
    Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
    Labeler DUNS
    300764032
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-02-28
    Public Version
    7
    Public Version Date
    2023-07-12
    Public Version Status
    Update
    Public Device Record Key
    8c0625e9-8bb4-4d58-859c-87bbda00f44a

    Device Description

    Single-Use Surgical Tool Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MCM IMPLANT, COCHLEAR

    GMDN Terms

    Code Name
    44069 ENT surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 09008737096939

    Customer Contacts

    Phone
    +1(888)633-3524
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P000025 079
    P000025 090

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -29 – 60 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -20.2 – 140 Degrees Fahrenheit
    Type
    Special Storage Condition, Specify
    Special Conditions
    may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date