BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SURGIPLUS

    DI: 74895237108019 · Model: 1 · KENPAX INTERNATIONAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SURGIPLUS
    Primary DI
    74895237108019
    Version / Model
    1
    Catalog Number
    68-7171-B
    Company Name
    KENPAX INTERNATIONAL LIMITED
    Labeler DUNS
    686206765
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-22
    Public Version
    2
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    cee441a5-2aa4-4eca-97a1-675f4068fae0

    Device Description

    Scrub Shirt, L A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LYU Accessory, Surgical Apparel

    GMDN Terms

    Code Name
    58382 Scrub suit, single-use

    Identifiers

    Type ID
    Package 84895237108016
    Primary 74895237108019