BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NDS

    DI: 04961333244102 · Model: NDS90Z0156 · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NDS
    Primary DI
    04961333244102
    Version / Model
    NDS90Z0156
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-15
    Public Version
    4
    Public Version Date
    2023-10-04
    Public Version Status
    Update
    Public Device Record Key
    81f411f1-38de-4aec-b275-735ec1e568c8

    Device Description

    ZWIRE G2 ACC. RADI. ULTRA 27 (PAIR)

    Device Characteristics

    Single Use
    No
    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
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KQM Camera, Surgical And Accessories

    GMDN Terms

    Code Name
    42513 Transportable medical equipment stand, non-powered

    Identifiers

    Type ID
    Primary 04961333244102