BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Damon Clear2

    DI: 00889989080544 · Model: 497-7585 · ORMCO CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Damon Clear2
    Primary DI
    00889989080544
    Version / Model
    497-7585
    Company Name
    ORMCO CORPORATION
    Labeler DUNS
    154614119
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2017-12-14
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    91adc445-96a4-4a57-9460-2ce4cea8d258

    Device Description

    U3L DAMON CLEAR2 .022 +11/+5/0 HOOK HIGH TQ

    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
    No
    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
    No

    Product Codes

    Code Name
    NJM Bracket, Ceramic, Orthodontic

    GMDN Terms

    Code Name
    58937 Orthodontic bracket, ceramic

    Identifiers

    Type ID
    Primary 00889989080544
    Unit of Use 20889989080548

    Customer Contacts

    Phone
    +18008541741
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Angulation: 0
    Device Size Text, specify Torque: +11
    Device Size Text, specify Slot Size: .022"