BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    HandCut

    DI: 08058341219188 · Model: PM18114 · M.D.L. S.R.L.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HandCut
    Primary DI
    08058341219188
    Version / Model
    PM18114
    Catalog Number
    PM18114
    Company Name
    M.D.L. S.R.L.
    Labeler DUNS
    447228586
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-04
    Public Version
    6
    Public Version Date
    2021-05-27
    Public Version Status
    Update
    Public Device Record Key
    0a328874-aa88-4c37-afd5-8d89cf3a6646
    Distribution End Date
    2021-05-14

    Device Description

    10 CS-DISPOSABLE NEEDLE 18G x114mm FOR SOFT TISSUE BIOPSY WITH MANUAL ACTION

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    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
    MJG Device, Percutaneous, Biopsy

    GMDN Terms

    Code Name
    16835 Soft-tissue biopsy procedure kit, non-medicated

    Identifiers

    Type ID
    Package 08058341219195
    Primary 08058341219188

    Device Sizes

    Type Value Unit Text
    Length 114 Millimeter
    Needle Gauge 18 Gauge