BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InTrack® Inserts

    DI: 00852621004147 · Model: N-10174v · VITALITEC INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    InTrack® Inserts
    Primary DI
    00852621004147
    Version / Model
    N-10174v
    Catalog Number
    N-10174v
    Company Name
    VITALITEC INTERNATIONAL, INC.
    Labeler DUNS
    121464288
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-26
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    9e90c455-bb7e-42cb-ae04-4f5044c95ed7

    Device Description

    Supplied as a pair for use in jaws of resuable clamps.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    DXC Clamp, Vascular

    GMDN Terms

    Code Name
    34948 Artery clamp

    Identifiers

    Type ID
    Primary 00852621004147
    Package 10852621004144

    Customer Contacts

    Phone
    5087476033
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K992980 000