BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Deluxe Wound Closure Tray

    DI: 00616784353425 · Model: 3534 · DYNAREX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Deluxe Wound Closure Tray
    Primary DI
    00616784353425
    Version / Model
    3534
    Company Name
    DYNAREX CORPORATION
    Labeler DUNS
    008124539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-21
    Public Version
    1
    Public Version Date
    2021-06-29
    Public Version Status
    New
    Public Device Record Key
    bd8be2f2-bdce-430b-b755-b2906c007df0

    Device Description

    Deluxe Wound Closure Tray that contains: (1) One-compartment tray with TYVEK® lid; (1) Iris scissor; (1) Mosquito hemostat, curved, 5"; (1) Towel 18" x 17", 3 ply; (5) Gauze pad 4" x 4", 8 ply; (1) PVP swabsticks, 3 each; (1) Alcohol prep pad; (1) Poly bag (red) with twist tie; (1) Fenestrated drape, 26" x 18"; (1) Adson tissue forceps; (1) Needle holder, 5"

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KDD Kit, Surgical Instrument, Disposable

    GMDN Terms

    Code Name
    46880 Wound closure set, topical

    Identifiers

    Type ID
    Package 00616784353432
    Primary 00616784353425