BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tex-Care Medical

    DI: 00632195002011 · Model: 91150-648 · Flynt/Amtex, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Tex-Care Medical
    Primary DI
    00632195002011
    Version / Model
    91150-648
    Company Name
    Flynt/Amtex, Inc.
    Labeler DUNS
    038730060
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-29
    Public Version
    2
    Public Version Date
    2021-12-22
    Public Version Status
    Update
    Public Device Record Key
    33fc9165-3889-4b43-9e99-4fcb477e21cb

    Device Description

    6X48 IMP STKT

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization, Ethylene Oxide

    Product Codes

    Code Name
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    47783 Patient surgical drape, single-use

    Identifiers

    Type ID
    Primary 00632195002011

    Premarket Submissions

    Submission Number Supplement Number
    K955749 000