BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SteriStay

    DI: 07350101640043 · Model: B2 · Toul Meditech AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SteriStay
    Primary DI
    07350101640043
    Version / Model
    B2
    Company Name
    Toul Meditech AB
    Labeler DUNS
    427895198
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-05
    Public Version
    2
    Public Version Date
    2020-10-06
    Public Version Status
    Update
    Public Device Record Key
    a20980a0-9146-4f87-a06e-e582060ba293

    Device Description

    SteriStay is a mobile instrument table intended for use in the operating environment that produces a directed, non-turbulent flow of air over sterile instruments and goods. The airflow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ORC Air Filter Portable Apparatus

    GMDN Terms

    Code Name
    36138 Surgical laminar airflow unit

    Identifiers

    Type ID
    Primary 07350101640043