BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SurgiCube drape

    DI: 07350101640098 · Model: SCDR180 · Toul Meditech AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SurgiCube drape
    Primary DI
    07350101640098
    Version / Model
    SCDR180
    Company Name
    Toul Meditech AB
    Labeler DUNS
    427895198
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-10
    Public Version
    3
    Public Version Date
    2021-06-22
    Public Version Status
    Update
    Public Device Record Key
    2270f729-40f8-479a-9ece-871c74a0181a

    Device Description

    Surgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the outcoming filtered air of the air flow unit and the environmental air, protecting the clean air area from potential (non-) viable particles.

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HMT Drape, Patient, Ophthalmic

    GMDN Terms

    Code Name
    62934 Surgical dressing/drape kit, single-use

    Identifiers

    Type ID
    Primary 07350101640098
    Package 07350101640081