BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ShroudGuard™

    DI: 00811836030075 · Model: 37303 · Dan Allen Surgical LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ShroudGuard™
    Primary DI
    00811836030075
    Version / Model
    37303
    Company Name
    Dan Allen Surgical LLC
    Labeler DUNS
    040876183
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-11-11
    Public Version
    1
    Public Version Date
    2024-11-19
    Public Version Status
    New
    Public Device Record Key
    138df1bf-65be-4156-8e83-23c4b4682187

    Device Description

    ShroudGuard OR Table Pedestal Protector for Merivaara Promerix™ and Promerix™ B3

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BWN Table And Attachments, Operating-Room

    GMDN Terms

    Code Name
    65222 Operating table pedestal protector

    Identifiers

    Type ID
    Primary 00811836030075