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    FDA Registration Active 🇮🇳 India

    Valleylab™ Insulated Micro-Needle Electrode, 9 cm, E1654B

    Reg #: 3018094310 · FEI: 3018094310 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    42
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medtronic Engineering and Innovation Center (MEIC)
    Registration Number
    3018094310
    FEI Number
    3018094310
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BSR Tech Park, Survey No.135, 138, 141 & 142 Nanakramguda Main Road
    City
    Hyderabad
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K955836

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    US Agent

    Business Name
    MEDTRONIC, INC.
    Contact Name
    Tania Pearson
    Address
    3576 Unocal Pl
    City
    Santa Rosa
    State
    CA
    ZIP
    95403
    Country
    US
    Email
    [email protected]
    Phone
    916 8138456

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Valleylab™ Insulated Micro-Needle Electrode, 9 cm, E1654B Edge Insulated Blade Electrode, (4", (10.16 cm), E1455-4 and E1455-4NSB Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HGNSB Edge Insulated Blade Electrode, Safety Sleeve, (4" (, 10.16 cm), E1455B4 Edge Insulated Blade Electrode, (6.5", (16.51 cm), E1455-6 and E1455-6NSB Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350HDB Edge Insulated Blade Electrode, Safety Sleeve, (2.75" (, 7 cm), E1455B Edge Blade Electrode, (6.5" (, 16.51 cm), E1450-6 and E1450-6NSB Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HS Valleylab™ Straight Micro-Needle Electrode, 2 cm, E1650 Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465NSB Edge Insulated Blade Electrode, Safety Sleeve, (4", (10.16 cm), E1455B-4NSB Edge Needle Electrode, (6.5" (, 16.51 cm), E1452-6 Edge Insulated Blade Electrode, (2.75", (7 cm), E1455 Edge™ Button Switch Pencil Blade Electrode, Holster, E2450H Edge Insulated Needle Electrode, Safety Sleeve, (2.8", (7.2 cm), E1465B and E1465BNSB Valleylab™ Angled Micro-Needle Electrode, 45 degree, 1 cm from tip, 3 cm, E1653 Micro-Needle Electrodes, E16XX Valleylab™ Straight Micro-Needle Electrode, 3 cm, E1651 Coated Electrodes Edge Blade Electrode, (3” (, 7.62 cm), E1450G and E1450GNSB Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350H Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HSNSB Edge Insulated Blade Electrode, Safety Sleeve (2.75", (7 cm), E1455NSB Edge Insulated Needle Electrode, Safety Sleeve, (4", (10.16 cm), E1465B-4 Edge Insulated Blade Electrode, Safety Sleeve, (2.75", (7 cm), E1455BNSB Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDBNSB Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HNSB Edge Insulated Needle Electrode, 6.5" (16.51 cm), E1465-6 Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HNSB Valleylab™ Angled Micro-Needle Electrode, 45 degree, 3 mm from tip, 3 cm, E1652 Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HGNSB Edge Needle Electrode, (2.8" (, 7.2 cm), E1452 Edge Blade Electrode, (4", (10.16 cm), E1450-NSB Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HDBNSB Edge™ Pencil Blade Electrode, Holster, E2250HNSB Edge Needle Electrode, (2.8", (7.2 cm), E1452NSB Edge Coated Blade Extended Electrode, ( 4" , (10.16 cm), E1450-4 Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465 Edge™ Pencil Blade Electrode, Holster, E2250H Edge Hex-locking Blade Electrode, (2.5” (, 6.35 cm), E1450X and E1450XNSB Edge™ Button Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2450HS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198