BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OPSITE INCISE 14X10CM CTN 10 or CTN 50

    DI: 05000223415464 · Model: 4963, 4975 · SMITH & NEPHEW MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OPSITE INCISE 14X10CM CTN 10 or CTN 50
    Primary DI
    05000223415464
    Version / Model
    4963, 4975
    Catalog Number
    4963, 4975
    Company Name
    SMITH & NEPHEW MEDICAL LIMITED
    Labeler DUNS
    216344051
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-18
    Public Version
    4
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    01c2babc-01e6-4705-89fe-c2992f4c833e

    Device Description

    Incise surgical drape

    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
    KGX Tape And Bandage, Adhesive

    GMDN Terms

    Code Name
    47783 Patient surgical drape, single-use

    Identifiers

    Type ID
    Package 05000223049638
    Primary 05000223415464
    Package 05000223414863
    Package 05000223049751
    Package 05000223414887