BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Coulmed Products Group

    DI: 00850003355801 · Model: DI-5503 · EXACT MEDICAL MANUFACTURING, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Coulmed Products Group
    Primary DI
    00850003355801
    Version / Model
    DI-5503
    Catalog Number
    DI-5503
    Company Name
    EXACT MEDICAL MANUFACTURING, INC.
    Labeler DUNS
    014464314
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-30
    Public Version
    2
    Public Version Date
    2020-02-06
    Public Version Status
    Update
    Public Device Record Key
    b8c97909-d262-441b-9c74-adf65e89c287

    Device Description

    Cassette Cover 61x61cm - 24"x24"

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    PM Exempt
    No
    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
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Package 00850003355818
    Primary 00850003355801

    Premarket Submissions

    Submission Number Supplement Number
    K101689 000