BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Tyvek™ Self-Seal Pouch

    DI: 10732224009015 · Model: TSP-181 · CROSSTEX INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    200

    Basic Information

    Brand Name
    Tyvek™ Self-Seal Pouch
    Primary DI
    10732224009015
    Version / Model
    TSP-181
    Company Name
    CROSSTEX INTERNATIONAL, INC.
    Labeler DUNS
    057728685
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    200
    Record Status
    Published
    Publish Date
    2022-05-03
    Public Version
    2
    Public Version Date
    2023-08-25
    Public Version Status
    Update
    Public Device Record Key
    642eaa04-4f32-47fa-a0aa-1a05405b4ccb
    Distribution End Date
    2023-08-24

    Device Description

    Tyvek™ Self-Seal Pouch, 3.5"× 9"/ 9×23cm

    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
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRG Wrap, sterilization

    GMDN Terms

    Code Name
    13735 Sterilization packaging, single-use

    Identifiers

    Type ID
    Package 50732224009013
    Primary 10732224009015
    Unit of Use 00732224009018

    Customer Contacts

    Phone
    +1(585)359-0167
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K123162 000