BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ECLIPSE PASSIVE

    DI: D9094633451 · Model: 463-345 · Ortho Arch Company Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ECLIPSE PASSIVE
    Primary DI
    D9094633451
    Version / Model
    463-345
    Catalog Number
    463-345
    Company Name
    Ortho Arch Company Inc
    Labeler DUNS
    020956330
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-21
    Public Version
    1
    Public Version Date
    2023-06-29
    Public Version Status
    New
    Public Device Record Key
    443b8a9c-49b4-415e-abe3-b9eb2bbe6a6b

    Device Description

    022 LA ECLIPSE PASSIVE SLB MBT -6T (5)

    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
    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
    No

    Product Codes

    Code Name
    EJF Bracket, Metal, Orthodontic

    GMDN Terms

    Code Name
    58818 Self-ligating orthodontic bracket

    Identifiers

    Type ID
    Primary D9094633451