BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORTH ARCH

    DI: D9098000651 · Model: 1/4' LIGATURE REMOVER/ DIRECTOR · Ortho Arch Company Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ORTH ARCH
    Primary DI
    D9098000651
    Version / Model
    1/4' LIGATURE REMOVER/ DIRECTOR
    Catalog Number
    800-065
    Company Name
    Ortho Arch Company Inc
    Labeler DUNS
    020956330
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-24
    Public Version
    1
    Public Version Date
    2022-10-03
    Public Version Status
    New
    Public Device Record Key
    7718b118-c326-478c-b298-848ba93bb15a

    Device Description

    LITE 1/4' LIGATURE REMOVER/ DIRECTOR - BLUE HANDLE

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DZN Instruments, Dental Hand

    GMDN Terms

    Code Name
    37413 Orthodontic ligature director

    Identifiers

    Type ID
    Primary D9098000651

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    – 50 Degrees Celsius