BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRISTINE SURGICAL LLC

    Reg #: 3019766696 · FEI: 3019766696 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    PRISTINE SURGICAL LLC
    Registration Number
    3019766696
    FEI Number
    3019766696
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    34125 Us Hwy 19 N Ste 200
    City
    Palm Harbor
    State
    FL
    ZIP
    34684
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223244

    Owner / Operator

    Firm Name
    Pristine Surgical LLC
    Operator Number
    10088394
    Address
    34125 US Highway 19N Ste 200
    City
    Palm Harbor
    State
    FL
    Postal Code
    34684
    Country
    US
    Correspondent
    Jeremy Moore

    Products

    Device Name Product Code
    Accessories, Arthroscopic NBH
    Arthroscope HRX

    Proprietary Names

    Summit High-Flow Cannula Pristine Arthroscopic Visualization System Summit Single Use Arthroscope

    Establishment Types

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