BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACELL, INC.

    Reg #: 3005920706 · FEI: 3005920706 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    20
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    ACELL, INC.
    Registration Number
    3005920706
    FEI Number
    3005920706
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6640 Eli Whitney Dr Ste 200
    City
    Columbia
    State
    MD
    ZIP
    21046
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101793

    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
    Dressing, Wound, Drug FRO
    Wound Dressing With Animal-Derived Material(S) KGN
    Mesh, Surgical, Collagen, Large Abdominal Wall Defects OXK
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Mesh, Surgical FTM
    Bandage, Cast ITG
    Mesh, Surgical, Collagen, Diaphragmatic Hernia OWV
    Intracardiac Patch Or Pledget, Biologically Derived PSQ

    Proprietary Names

    Medihoney Gel Dressings MicroMatrix Medihoney Cytal® Wound Matrix Cytal® Burn Matrix Gentrix" Surgical Matrix Thick MicroMatrix® UBM Particulate Medihoney Honeycolloid Dressing Gentrix Surgical Matrix Plus Gentrix Surgical Matrix Hiatal Gentrix Surgical Matrix Thin Gentrix Surgical Matrix Cytal Wound Matrix 2-Layer Cytal Burn Matrix Cytal Wound Matrix 3-Layer Cytal Wound Matrix 1-Layer Cytal Wound Matrix 6-Layer Medihoney Dressing with Active Hone Cardion" for Pericardial Repair MicroMatrix Flex Medihoney Wound and Burn Dressing

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device