BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Surge Cardiovascular

    DI: 00817278010989 · Model: 213-013NS · Alliant Enterprises, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Surge Cardiovascular
    Primary DI
    00817278010989
    Version / Model
    213-013NS
    Catalog Number
    213-013NS
    Company Name
    Alliant Enterprises, LLC
    Labeler DUNS
    121170653
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    9ed168dc-37fe-4ef3-909d-2bdf014f2d10

    Device Description

    Suture Guide, 3 pack, Non-Sterile

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    GEJ Carrier, Ligature

    GMDN Terms

    Code Name
    36129 Suturing guide

    Identifiers

    Type ID
    Package 10817278010986
    Primary 00817278010989