BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Custom Healthcare Systems Inc.

    DI: 00811870030536 · Model: UNC-9538 · 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
    00811870030536
    Version / Model
    UNC-9538
    Company Name
    Manus Medical, LLC
    Labeler DUNS
    800604196
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-25
    Public Version
    4
    Public Version Date
    2023-06-08
    Public Version Status
    Update
    Public Device Record Key
    a0e79f77-350b-44f0-a48c-5054ee269a0a

    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    OKV Obstetrical Kit

    GMDN Terms

    Code Name
    10243 Infant care kit

    Identifiers

    Type ID
    Package 20811870030530
    Primary 00811870030536