BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    IcePro Socket TT

    Reg #: 3003764610 · FEI: 3003764610 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    89
    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
    Prosthesis, Thigh Socket, External Component ISS

    Proprietary Names

    IcePro Socket TT IcePro Socket TT Diagnostic Medipro Liner Sensitive Locking Iceross Seal-In X Iceross Activa Cushion Iceross Seal-In Transfemoral Direct Socket TT Iceross Dermo Junior Locking Echo Seal Natural Custom Liners Soft C Direct Socket Tool Kit Iceross Dermo Cushion Iceflex Balance Sleeve Connect TF Iceross Comfort Locking Relax Cushion AKOS Protect Locking Iceform Locking Liner Iceross Post-Op TF Iceross Transfemoral Locking First Iceross Upper-X Locking Relax Locking Iceross Dermo Seal-In Iceform Sleeve Iceross Direct Casting Liner Iceform Cushion Liner Iceross Dermo Locking Iceross Interface Sheath Iceross Stabilo Junior Locking Origin OTS Liners Iceross Comfort Cushion Iceross Seal-In V Genu Sleeve Icross Pads Iceross Seal-In X seals Iceross Seal-In X TF Natural Custom Wave Liners Iceross Sleeve Origin Custom Wave Liners Iceross Seal-In X Locking Aura Seal Relax Transfemoral Iceross Seal-In X5 TF Origin Custom Liners Iceross Dermo Uniform Locking Iceross Post-Op TT Iceross Synergy Locking Direct Socket TF Iceross Curvemaster 4Seal Classic Ossur Brim Iceross Dermo Uniform Cushion Iceross Socks Iceross Distal Cup Iceross Sport Locking Iceross Seal-In X5 Natural OTS Liners Iceross Original Locking Iceross Synergy Cushion Aspire Locking Protect Cushion Definitive Socket TF Evolution Custom Locking Protector Sleeve Aspire TF Locking 4Seal Senso Check Socket TF Pressure Pads Origin Check Socket TT Chameleon Iceross Seal-In Socks Definitive Socket TT Evolution Custom Hip Evolution Liner Origin XV Knee Lanyard kit for Connect TF AeroFit Seal-In Origin X Origin Sleeve Evolution Custom Cushion AeroFit Socket IcePro Socket TF IcePro Socket TF Diagnostic Iceross Seal-In X Locking TF

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device