BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DOFF n DONNER ROLLY

    DI: 07613378302572 · Model: 358496 · SIGVARIS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DOFF n DONNER ROLLY
    Primary DI
    07613378302572
    Version / Model
    358496
    Catalog Number
    358496
    Company Name
    SIGVARIS INC
    Labeler DUNS
    189738719
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-27
    Public Version
    1
    Public Version Date
    2025-02-04
    Public Version Status
    New
    Public Device Record Key
    7ab25863-5588-4e6a-8cb8-fb0b41a2cf7c

    Device Description

    A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IKX Aid, Transfer

    GMDN Terms

    Code Name
    31050 Assistive sock/pantyhose dressing device

    Identifiers

    Type ID
    Primary 07613378302572

    Customer Contacts

    Phone
    +1(800)322-7744
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify No Device Sizes