BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBD-040-X)

    Reg #: 2081135 · FEI: 2081135 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PRO-DEX, INC.
    Registration Number
    2081135
    FEI Number
    2081135
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2361 McGaw Avenue
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Owner / Operator

    Firm Name
    PRO-DEX, INC.
    Operator Number
    2081135
    Address
    2361 McGaw Avenue, --
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US

    Products

    Device Name Product Code
    Motor, Surgical Instrument, Ac-Powered GEY

    Proprietary Names

    Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBD-040-X) Pro-Dex Surgical Driver (PDSD-5000-X) Atlas Pro Driver (APD-1000-1) Atlas Pro Driver Hex Collet (APD-CA-001-1) Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1) PDCMF Power Driver (PDCMF-1000-X)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device