BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Integra2421 (CH2) - OS Osteo-conductive Scaffold-Putty

    Reg #: 3013820501 · FEI: 3013820501 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    3013820501
    FEI Number
    3013820501
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Nucifora Blvd
    City
    Chester
    State
    NY
    ZIP
    10918
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062353

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    9072619
    Address
    5960 Heisley Road, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    Integra2421 (CH2) - OS Osteo-conductive Scaffold-Putty Integra2421 (CH2) - OsteoStrux Osteo-conductive Scaffold-Putty Integra2421 (CH2) - Collage Osteo-conductive Scaffold-Putty

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)