BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Reflections

    DI: 00190730005595 · Model: REF-031 · ORTHO TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Reflections
    Primary DI
    00190730005595
    Version / Model
    REF-031
    Company Name
    ORTHO TECHNOLOGY, INC.
    Labeler DUNS
    781772017
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    0f6f6630-241e-4ae7-bfe5-51b6315c4437

    Device Description

    Reflections 018 U 4/5 Hk Roth Rx -7º Tor. 0º Ang.(10PK)

    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
    Yes
    PM Exempt
    No
    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
    NJM Bracket, ceramic, orthodontic

    GMDN Terms

    Code Name
    58937 Orthodontic bracket, ceramic

    Identifiers

    Type ID
    Primary 00190730005595

    Premarket Submissions

    Submission Number Supplement Number
    K922499 000