BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monarch™ Overhead Arm Positioner

    DI: 00841439110676 · Model: OAP100 · MEDTEC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monarch™ Overhead Arm Positioner
    Primary DI
    00841439110676
    Version / Model
    OAP100
    Catalog Number
    OAP100
    Company Name
    MEDTEC, INC.
    Labeler DUNS
    103977526
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-02
    Public Version
    9
    Public Version Date
    2021-10-13
    Public Version Status
    Update
    Public Device Record Key
    7b70ea63-0e96-4d87-8bea-b9220ec461ee

    Device Description

    Wingboard with attachment to C-Qual™ breastboard

    Device Characteristics

    Single Use
    No
    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
    MR Conditional
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYE Accelerator, linear, medical

    GMDN Terms

    Code Name
    40899 Radiological breast positioner, non-wearable

    Identifiers

    Type ID
    Primary 00841439110676

    Customer Contacts

    Phone
    +1(712)737-8688
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K974703 000

    Device Sizes

    Type Value Unit Text
    Width 59.3 Centimeter
    Length 63.2 Centimeter