BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prometheus Omni Splint Flat

    DI: 05060483570105 · Model: PML115 · SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prometheus Omni Splint Flat
    Primary DI
    05060483570105
    Version / Model
    PML115
    Catalog Number
    PML115
    Company Name
    SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
    Labeler DUNS
    219545612
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-04
    Public Version
    1
    Public Version Date
    2023-05-12
    Public Version Status
    New
    Public Device Record Key
    8213b5fb-3efa-4854-9e0e-b84e2c322089
    Distribution End Date
    2030-05-04

    Device Description

    The Prometheus Omni Splint™ is intended to be used to aid support and immobilize a patient’s limb(s).

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile

    GMDN Terms

    Code Name
    64881 First aid limb splint, mouldable, single-use

    Identifiers

    Type ID
    Primary 05060483570105