BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Disposable Insulin Pen Needle

    Reg #: 3021286079 · FEI: 3021286079 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PURCEL LABS LLC
    Registration Number
    3021286079
    FEI Number
    3021286079
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10537 Santa Monica Blvd. Unit 300
    City
    Los Angeles
    State
    CA
    ZIP
    90025
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181069

    Owner / Operator

    Firm Name
    PurCel Labs LLC
    Operator Number
    10083940
    Address
    10537 Santa Monica Blvd. Unit 300
    City
    Los Angeles
    State
    CA
    Postal Code
    90025
    Country
    US
    Correspondent
    Doron Wipranik

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Disposable Insulin Pen Needle

    Establishment Types

    Repack or Relabel Medical Device