BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTEGRA LIFESCIENCES CORPORATION

    Reg #: 1121308 · FEI: 1121308 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    41
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    INTEGRA LIFESCIENCES CORPORATION
    Registration Number
    1121308
    FEI Number
    1121308
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    105 and 109 MORGAN LANE
    City
    PLAINSBORO
    State
    NJ
    ZIP
    08536
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041620
    PMA Number
    P840062

    Owner / Operator

    Firm Name
    Integra LifeSciences Corporation
    Operator Number
    9004007
    Address
    1100 Campus Rd
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US

    Products

    Device Name Product Code
    Material, Dressing, Surgical, Polylactic Acid LPG
    Cuff, Nerve JXI
    Wound Dressing With Animal-Derived Material(S) KGN
    Bone Grafting Material, Synthetic LYC
    Dura Substitute GXQ
    Device, Dermal Replacement MDD
    Agent, Absorbable Hemostatic, Collagen Based LMF
    Dressing, Wound And Burn, Interactive MGR
    Mesh, Surgical FTM

    Proprietary Names

    HeliTape Absorbable Collagen Wound Dressing CollaPlug Absorbable Collagen Wound Dressing HeliCote Absorbable Collagen Wound Dressing HeliPlug Absorbable Collagen Wound Dressing OraTape Absorbable Collagen Wound Dressing OraPlug Absorbable Collagen Wound Dressing CollaCote Absorbable Collagen Wound Dressing CollaTape Absorbable Collagen Wound Dressing NeuraWrap Nerve Protector INTEGRA Flowable Wound Matrix OraMem Sustained Absorbable Collagen Membrane Biomend Extend Absorbable Collagen Membrane HeliMend Advanced Absorbable Collagen Membrane DuraGen Dural Graft Matrix INTEGRA Wound Matrix (Thin) DuraGen Secure Dural Regeneration Matrix Suturable DuraGen Dural Regenration Matrix INTEGRA Wound Matrix INTEGRA Matrix Wound Dressing Integra Meshed Bilayer Wound Matrix NeuraGen 3D Integra Dermal Regeneration Template Single Layer Integra Dermal Regeneration Template Single Layer Thin Integra Meshed Dermal Regeneration Template (OUS) DuraGen Plus Dural Regeneration Matrix DURAGEN PLUS ADHESION BARRIER MATRIX SUTURABLE DURAGEN DURAL REGENERATION METRIX DuraGen XS Dural Regeneration Matrix Helistat Absorbable Collagen Hemostatic Sponge Helitene Absorbable Collagen Hemostatic Agent OraFOAM Absorbable Collagen Hemostatic Sponge INTEGRA Dermal Regeneration Template INTEGRA Meshed Dermal Regeneration Template Integra Omnigraft Dermal Regeneration Matrix OraMem Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane HeliMend Absorbable Collagen Membrane TenoGlide Tendon Protector INTEGRA Bilayer Matrix Wound Dressing INTEGRA Bilayer Wound Matrix NeuraGen Nerve Guide

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only