BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    DAN-33825WG to Safersonic Long with Gel

    Reg #: 3003623887 · FEI: 3003623887 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHARMASEPT LTD. MEDICAL PRODUCTS
    Registration Number
    3003623887
    FEI Number
    3003623887
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Shaham St., Northern Industrial Park
    City
    Caesarea Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K190591

    Owner / Operator

    Firm Name
    PHARMASEPT LTD. MEDICAL PRODUCTS
    Operator Number
    9045710
    Address
    9 Shaham St., Northern Industrial Park
    City
    Caesarea
    State
    IL-NOTA
    Postal Code
    3088900
    Country
    IL

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Media, Coupling, Ultrasound MUI

    Proprietary Names

    DAN-33825WG to Safersonic Long with Gel DAN-33812WG to Safersonic Conti with Gel S11101 Pajunk Labeled Safersonic Single with Gel S11103 Pajunk Labeled Safersonic Conti with Gel DAN-33505NWG Safersonic Medium Narrow with Gel DAN-33805WG Safersonic Medium with Gel DAN-33512NWG Safersonic Conti Narrow with Gel DAN-33803WG Safersonic Single with Gel

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)