BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Custom Medical Specialties, Inc.

    DI: 00815849020115 · Model: CMS-2015BB-NS · CUSTOM ASSEMBLIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Custom Medical Specialties, Inc.
    Primary DI
    00815849020115
    Version / Model
    CMS-2015BB-NS
    Company Name
    CUSTOM ASSEMBLIES, INC.
    Labeler DUNS
    948904735
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-21
    Public Version
    3
    Public Version Date
    2018-11-08
    Public Version Status
    Update
    Public Device Record Key
    d328bad3-a496-4fe4-b52e-e2fdbabd3de1

    Device Description

    20" x 15" BandBag - Non-Sterile

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    47782 Patient surgical drape, single-use, non-sterile

    Identifiers

    Type ID
    Package 00815849020696
    Primary 00815849020115