BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WrapPel Wrapper

    DI: 00634916101720 · Model: 27766183 · STANDARD TEXTILE CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    36

    Basic Information

    Brand Name
    WrapPel Wrapper
    Primary DI
    00634916101720
    Version / Model
    27766183
    Catalog Number
    27766183
    Company Name
    STANDARD TEXTILE CO., INC.
    Labeler DUNS
    006999858
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    36
    Record Status
    Published
    Publish Date
    2018-01-29
    Public Version
    4
    Public Version Date
    2019-11-08
    Public Version Status
    Update
    Public Device Record Key
    a676212a-1313-4c70-a268-1368857897b5

    Device Description

    STERILE WRAP WrapPel KAUM 54X54 - RM (98 7733) USE: 27766602

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

    Product Codes

    Code Name
    FRG Wrap, Sterilization

    GMDN Terms

    Code Name
    40517 Sterilization packaging, reusable

    Identifiers

    Type ID
    Primary 00634916101720
    Unit of Use 10634916101720

    Customer Contacts

    Phone
    1-800-999-0400
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K923408 000