BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 00848486016814 · Model: 111618 · MAKO SURGICAL CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    NA
    Primary DI
    00848486016814
    Version / Model
    111618
    Catalog Number
    111618
    Company Name
    MAKO SURGICAL CORP.
    Labeler DUNS
    175239677
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2023-08-25
    Public Version Status
    Update
    Public Device Record Key
    2984efbc-383a-4d92-a4b8-ccf347a96a71

    Device Description

    Leg Positioner Disposables Kit

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FMP Protector, skin pressure

    GMDN Terms

    Code Name
    48139 Orthopaedic knee/leg holder liner

    Identifiers

    Type ID
    Primary 00848486016814