BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pinnacle®

    DI: 00190707112585 · Model: 360-91-3432 · Ortho Organizers, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    Pinnacle®
    Primary DI
    00190707112585
    Version / Model
    360-91-3432
    Company Name
    Ortho Organizers, Inc.
    Labeler DUNS
    062165188
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2025-09-26
    Public Version
    3
    Public Version Date
    2025-12-30
    Public Version Status
    Update
    Public Device Record Key
    8458a104-fc12-479c-821d-5b0151a44f52

    Device Description

    Pinnacle .018 R LR4 HK G/O -17T 0A 4DO (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
    MR Unsafe
    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
    EJF BRACKET, METAL, ORTHODONTIC

    GMDN Terms

    Code Name
    46581 Orthodontic bracket, metal

    Identifiers

    Type ID
    Unit of Use 10190707112582
    Primary 00190707112585