BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PHOENIX

    DI: 00810033837609 · Model: P-300-201 · AURADONICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PHOENIX
    Primary DI
    00810033837609
    Version / Model
    P-300-201
    Company Name
    AURADONICS INC.
    Labeler DUNS
    608537379
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-31
    Public Version
    2
    Public Version Date
    2021-06-22
    Public Version Status
    Update
    Public Device Record Key
    43cccc2a-7239-4cc3-bc38-5ccbb82fb1c8

    Device Description

    KEYTIES - CLEAR, 1000 devices per package, see www.auradonics.com

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ECI Band, Elastic, Orthodontic

    GMDN Terms

    Code Name
    41677 Orthodontic archwire/bracket ligature

    Identifiers

    Type ID
    Primary 00810033837609

    Customer Contacts

    Phone
    8567648866
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    6 – 25 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Away from sunlight or strong light