BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OnPoint Lite System

    DI: 00851582006108 · Model: 24-4200 · BIOVISION TECHNOLOGIES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OnPoint Lite System
    Primary DI
    00851582006108
    Version / Model
    24-4200
    Catalog Number
    BMT01197-00001
    Company Name
    BIOVISION TECHNOLOGIES, LLC
    Labeler DUNS
    166160106
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-27
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    8a7e2283-1a3c-4cb6-8986-5ee43ff05efa

    Device Description

    OnPoint Lite Visualization System

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    35616 Endoscopic video imaging system

    Identifiers

    Type ID
    Primary 00851582006108

    Customer Contacts

    Phone
    303-237-9608
    Email
    [email protected]
    Phone
    904-741-4400
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K143705 000