BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Loop™

    DI: 00810038093604 · Model: CLL02 · GARRISON DENTAL SOLUTIONS, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Loop™
    Primary DI
    00810038093604
    Version / Model
    CLL02
    Catalog Number
    CLL02
    Company Name
    GARRISON DENTAL SOLUTIONS, L.L.C.
    Labeler DUNS
    057647005
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-22
    Public Version
    1
    Public Version Date
    2023-05-01
    Public Version Status
    New
    Public Device Record Key
    178d46d7-a332-4ac0-a1e7-f61aa5152cbb

    Device Description

    Loaner: Loop™ LED Curing Light Handpiece

    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
    No
    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
    Yes
    Sterilization Methods
    High-level Disinfectant

    Product Codes

    Code Name
    EBZ Activator, Ultraviolet, For Polymerization

    GMDN Terms

    Code Name
    35775 Dental/surgical polymerization lamp

    Identifiers

    Type ID
    Primary 00810038093604

    Customer Contacts

    Phone
    8884370032
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K200775 000