BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Custom Healthcare Systems, Inc.

    DI: 00811870036347 · Model: B9-16938A · Manus Medical, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Custom Healthcare Systems, Inc.
    Primary DI
    00811870036347
    Version / Model
    B9-16938A
    Company Name
    Manus Medical, LLC
    Labeler DUNS
    800604196
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-14
    Public Version
    4
    Public Version Date
    2023-06-08
    Public Version Status
    Update
    Public Device Record Key
    1775459c-4a77-4192-b0c0-7b376d2f2153

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    LRO General Surgery Tray

    GMDN Terms

    Code Name
    33961 General surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Package 20811870036341
    Primary 00811870036347