BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tru-Chrome

    DI: 00885797015686 · Model: A00811 · Rmo, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    Tru-Chrome
    Primary DI
    00885797015686
    Version / Model
    A00811
    Company Name
    Rmo, Inc.
    Labeler DUNS
    007058183
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2024-08-16
    Public Version
    1
    Public Version Date
    2024-08-26
    Public Version Status
    New
    Public Device Record Key
    43c6858b-4f37-47bf-b2c9-9e6de4ed7eab

    Device Description

    ARCH BLK SS MN 018X022 PKG 10

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZC Wire, Orthodontic

    GMDN Terms

    Code Name
    41397 Orthodontic archwire

    Identifiers

    Type ID
    Unit of Use 00000008857972
    Primary 00885797015686