BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Custom Medical Specialties, Inc.

    DI: 00815849024847 · Model: CMS-4846-R4 · CUSTOM ASSEMBLIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Custom Medical Specialties, Inc.
    Primary DI
    00815849024847
    Version / Model
    CMS-4846-R4
    Company Name
    CUSTOM ASSEMBLIES, INC.
    Labeler DUNS
    948904735
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-13
    Public Version
    1
    Public Version Date
    2023-09-21
    Public Version Status
    New
    Public Device Record Key
    1abfd552-13ac-496f-819d-f7a5a959337e

    Device Description

    Procedure Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    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
    LRO General Surgery Tray

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00815849024847