BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Smartwire InGager

    DI: 00850018135399 · Model: 85001 · SWIFT HEALTH SYSTEMS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Smartwire InGager
    Primary DI
    00850018135399
    Version / Model
    85001
    Catalog Number
    85001
    Company Name
    SWIFT HEALTH SYSTEMS INC.
    Labeler DUNS
    884398210
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-11-07
    Public Version
    1
    Public Version Date
    2021-11-15
    Public Version Status
    New
    Public Device Record Key
    2d62858b-0381-45f2-8397-ba49505e1aeb

    Device Description

    An orthodontic reusable instrument intended for use with the InBrace Teeth Straightening System (Gen 2.0) to insert, ligate and remove Smartwires from brackets.

    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
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DZN Instruments, Dental Hand

    GMDN Terms

    Code Name
    62086 Self-ligating orthodontic bracket open/close tool

    Identifiers

    Type ID
    Primary 00850018135399