BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NORTHEAST SCIENTIFIC, INC.

    Reg #: 3005467144 · FEI: 3005467144 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    20
    Establishment Types
    4
    Classifications
    7

    Registration Details

    Registration Name
    NORTHEAST SCIENTIFIC, INC.
    Registration Number
    3005467144
    FEI Number
    3005467144
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2142 Thomaston Ave
    City
    Waterbury
    State
    CT
    ZIP
    06704
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200195

    Owner / Operator

    Firm Name
    NORTHEAST SCIENTIFIC, INC.
    Operator Number
    9079660
    Address
    2142 Thomaston Avenue, --
    City
    Waterbury
    State
    CT
    Postal Code
    06704
    Country
    US
    Correspondent
    Steven - Miller

    Products

    Device Name Product Code
    Catheter, Ultrasound, Intravascular OBJ
    Reprocessed Intravascular Ultrasound Catheter OWQ
    Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed NUJ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Tray, Surgical LRP
    Reprocessed Atherectomy Catheter QTF
    Retractor GAD

    Proprietary Names

    NES Reprocessed Visions PV 14P RX Digital IVUS Catheter NES Reprocessed Visions PV 18 Digital IVUS Catheter ViewFlex™ Eco Reprocessed ICE Catheter ViewFlex Xtra Reprocessed ICE Catheter NES Reprocessed RF Stylet (RFS) NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter NES Reprocessed Varicose Vein RF Catheter 700004 Vein Ablation Pack 700005 Vein Ablation Pack NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter NES Reprocessed 2mm RX Turbo Elite Laser Atherectomy Catheter NES Reprocessed 2mm OTW Turbo Elite Laser Atherectomy Catheter NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter EsoSure NES IVUS Smart Reprocessed IVUS Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility