BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    E-Chain

    DI: 00192029038413 · Model: 389-066 · TP ORTHODONTICS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E-Chain
    Primary DI
    00192029038413
    Version / Model
    389-066
    Company Name
    TP ORTHODONTICS INC
    Labeler DUNS
    005432299
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-15
    Public Version
    1
    Public Version Date
    2021-02-23
    Public Version Status
    New
    Public Device Record Key
    64367c08-137d-41ee-9765-8ebbf744246f

    Device Description

    Navy Blue Medium

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    62073 Orthodontic inter-bracket elastic chain

    Identifiers

    Type ID
    Primary 00192029038413