BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Positioning Cushion

    DI: 00841439101186 · Model: 301082 · MEDTEC, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Positioning Cushion
    Primary DI
    00841439101186
    Version / Model
    301082
    Catalog Number
    301082
    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
    8
    Public Version Date
    2023-08-21
    Public Version Status
    Update
    Public Device Record Key
    9050ba48-6648-4e03-b022-f9677e95708f

    Device Description

    10 degree wedge

    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 Safe
    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
    LNH System, nuclear magnetic resonance imaging

    GMDN Terms

    Code Name
    40899 Radiological breast positioner, non-wearable

    Identifiers

    Type ID
    Primary 00841439101186

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K060737 000
    K180021 000

    Device Sizes

    Type Value Unit Text
    Length 83 Centimeter
    Width 50 Centimeter