BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    Formfit Wrist and Forearm Universal

    Reg #: 3003764610 · FEI: 3003764610 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OSSUR H/F
    Registration Number
    3003764610
    FEI Number
    3003764610
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GRJOTHALS 1-5
    City
    REYKJAVIK
    Country
    IS

    Owner / Operator

    Firm Name
    OSSUR Americas
    Operator Number
    9026971
    Address
    200 Spectrum Center Drive, Suite 700
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    US Agent

    Business Name
    Ossur
    Contact Name
    Katla Axelsdottir
    Address
    200 Spectrum Center Drive, Suite 700
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3823833

    Products

    Device Name Product Code
    Splint, Hand, And Components ILH

    Proprietary Names

    Formfit Wrist and Forearm Universal Formfit Wrist Formfit Wrist & Forearm Formfit Pediatric Thumb Spica Formfit Pediatric Wrist Universal Formfit Thumb OA Day Formfit Thumb OA Night Wrist Brace Formfit Pro Wrist Formfit Universal Wrist Spectra Wrist Brace Exoform Wrist Universal Thumb Splint Formfit Thumb Formfit Universal Thumb Exoform Carpal Tunnel Wrist Thumb Spica

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility