BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lares Research

    DI: D950131242360 · Model: 557 ProStyle SF Lite · LARES RESEARCH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lares Research
    Primary DI
    D950131242360
    Version / Model
    557 ProStyle SF Lite
    Catalog Number
    13124-236
    Company Name
    LARES RESEARCH
    Labeler DUNS
    009127838
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-07
    Public Version
    1
    Public Version Date
    2023-06-15
    Public Version Status
    New
    Public Device Record Key
    2462749d-c4a5-4b64-9238-56f3e9634625

    Device Description

    557 ProStyle SF Lite Swivel Fiber Optic Ceramic ball bearing

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    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
    EFB Handpiece, Air-Powered, Dental

    GMDN Terms

    Code Name
    66228 Dental surgical power tool motor, pneumatic

    Identifiers

    Type ID
    Primary D950131242360

    Customer Contacts

    Phone
    5303451767
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K141221 000