BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    6-Wire Halo

    DI: B0325561600 · Model: 556160 · SACRED HEART MEDICAL,INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    6-Wire Halo
    Primary DI
    B0325561600
    Version / Model
    556160
    Catalog Number
    556160
    Company Name
    SACRED HEART MEDICAL,INC.
    Labeler DUNS
    832763002
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-15
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    319671f0-a08c-45ba-97c8-5dc8fbd234be

    Device Description

    1.5 Fr, 120 cm, 6-Wire NiTi Tipless Stone Basket

    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
    No
    PM Exempt
    Yes
    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
    FFL Dislodger, Stone, Basket, Ureteral, Metal

    GMDN Terms

    Code Name
    44333 Urinary stone retrieval basket, single-use

    Identifiers

    Type ID
    Primary B0325561600