BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ortho Technology®

    DI: 00190707192952 · Model: 550-413D · Ortho Organizers, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ortho Technology®
    Primary DI
    00190707192952
    Version / Model
    550-413D
    Company Name
    Ortho Organizers, Inc.
    Labeler DUNS
    062165188
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-23
    Public Version
    3
    Public Version Date
    2025-12-30
    Public Version Status
    Update
    Public Device Record Key
    410aacb9-d44c-4bb8-8617-595480534f63

    Device Description

    DLR-Multi-Adj Facemask Regular Camoflage MULTIADJUSTABLE

    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
    MR Unsafe
    Direct Marking Exempt
    No
    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
    DZB Headgear, extraoral, orthodontic

    GMDN Terms

    Code Name
    31757 Orthodontic extraoral headgear

    Identifiers

    Type ID
    Primary 00190707192952

    Premarket Submissions

    Submission Number Supplement Number
    K000358 000