BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Regard™

    DI: 00326053117909 · Model: NTRLEXMM3-REG · RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Regard™
    Primary DI
    00326053117909
    Version / Model
    NTRLEXMM3-REG
    Catalog Number
    400595
    Company Name
    RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
    Labeler DUNS
    134472476
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-25
    Public Version
    1
    Public Version Date
    2021-09-02
    Public Version Status
    New
    Public Device Record Key
    cfc1d437-3cd1-4588-af2e-a3700ab40237

    Device Description

    NTRL EXM GLV M

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZA Polymer Patient Examination Glove

    GMDN Terms

    Code Name
    56286 Nitrile examination/treatment glove, non-powdered, non-antimicrobial

    Identifiers

    Type ID
    Package 10326053117906
    Primary 00326053117909