BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Medichoice

    DI: 10885632126413 · Model: STB651 · OWENS & MINOR DISTRIBUTION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Medichoice
    Primary DI
    10885632126413
    Version / Model
    STB651
    Company Name
    OWENS & MINOR DISTRIBUTION, INC.
    Labeler DUNS
    007941230
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-29
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    bc979b5e-80bf-4383-b14b-4dc6cc4176fe

    Device Description

    X Rx Tray Biopsy Soft-Tissue Basic Single-Patient Use Latex-Free Sterile MediChoice

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FCH TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS

    GMDN Terms

    Code Name
    61922 Soft-tissue biopsy procedure kit, medicated

    Identifiers

    Type ID
    Package 50885632126411
    Primary 10885632126413

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Type
    Special Storage Condition, Specify
    Special Conditions
    Avoid freezing and excessive heat
    Type
    Handling Environment Temperature
    Temperature Range
    68 – 77 Degrees Fahrenheit