BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Span-America

    DI: H933826581 · Model: SOFT PEDAL · SPAN-AMERICA MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Span-America
    Primary DI
    H933826581
    Version / Model
    SOFT PEDAL
    Catalog Number
    82658-1
    Company Name
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Labeler DUNS
    073704413
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-15
    Public Version
    2
    Public Version Date
    2025-07-17
    Public Version Status
    Update
    Public Device Record Key
    84aac709-0d48-4a43-b474-9a365914551c
    Distribution End Date
    2024-05-06

    Device Description

    SOFT PEDAL CUSHION 18 X 16 W/SYNERGEL 1/CS

    Device Characteristics

    Single Use
    No
    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
    KIC Cushion, Flotation

    GMDN Terms

    Code Name
    44511 Gel-filled chair cushion

    Identifiers

    Type ID
    Primary H933826581