BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prostate Caddy Rectal Balloon

    DI: 10860005263100 · Model: 3301 · Myriad Medical, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Prostate Caddy Rectal Balloon
    Primary DI
    10860005263100
    Version / Model
    3301
    Catalog Number
    3301
    Company Name
    Myriad Medical, LLC
    Labeler DUNS
    842448610
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2020-09-23
    Public Version
    1
    Public Version Date
    2020-10-01
    Public Version Status
    New
    Public Device Record Key
    9158ba31-d538-4d44-96e9-314dda527fcc

    Device Description

    Prostate Immobilization device. Rectal Balloon, single use, non-sterile. Box of 50.

    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
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PCT Prostate Immobilizer Rectal Balloon

    GMDN Terms

    Code Name
    31965 Rectal probe

    Identifiers

    Type ID
    Unit of Use 00860005263103
    Primary 10860005263100