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    FDA UDI In Commercial Distribution 🇺🇸 United States

    MD Orthopaedics

    DI: 00810060885482 · Model: AFO-3-PFS-R-COLORS · MD ORTHOPAEDICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MD Orthopaedics
    Primary DI
    00810060885482
    Version / Model
    AFO-3-PFS-R-COLORS
    Company Name
    MD ORTHOPAEDICS, INC.
    Labeler DUNS
    146220269
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-06
    Public Version
    4
    Public Version Date
    2022-12-15
    Public Version Status
    Update
    Public Device Record Key
    90513d37-15ef-49d7-9375-01fab1fc1c08

    Device Description

    AFO-PFS SIZE 3 RIGHT CUSTOM COLOR

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    KNP Orthosis, Corrective Shoe

    GMDN Terms

    Code Name
    36206 Ankle/foot orthosis

    Identifiers

    Type ID
    Primary 00810060885482