BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Summit Single Use Arthroscope

    Reg #: 3019766696 · FEI: 3019766696 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PRISTINE SURGICAL LLC
    Registration Number
    3019766696
    FEI Number
    3019766696
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1750 Elm Street, 6th Floor
    City
    Manchester
    State
    NH
    ZIP
    03104
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223244

    Owner / Operator

    Firm Name
    Pristine Surgical LLC
    Operator Number
    10088394
    Address
    1750 Elm Street, 6th Floor
    City
    Manchester
    State
    NH
    Postal Code
    03104
    Country
    US
    Correspondent
    Jeremy Moore

    Products

    Device Name Product Code
    Arthroscope HRX

    Proprietary Names

    Summit Single Use Arthroscope Pristine Arthroscopic Visualization System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198