BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SecureShield© Angiography 13" x 16" Scatter Reducing Drape

    DI: 10860004894640 · Model: SS-5300 · Barrier Technologies, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SecureShield© Angiography 13" x 16" Scatter Reducing Drape
    Primary DI
    10860004894640
    Version / Model
    SS-5300
    Company Name
    Barrier Technologies, LLC
    Labeler DUNS
    621134084
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-29
    Public Version
    1
    Public Version Date
    2022-09-06
    Public Version Status
    New
    Public Device Record Key
    1fae5312-897b-4cd7-a984-788f26d950b0

    Device Description

    Ultimate protection for femoral artery and radial access procedures. Unique shield design protects hands, face and body. Will not inhibit the physicians technique. The small fenestration and the slit to the shield edge provide maximum protection to hands and body and excellent maneuverability around the sheath.

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPY Shield, Protective, Personnel

    GMDN Terms

    Code Name
    64134 Patient radiation shielding pad/drape, single-use

    Identifiers

    Type ID
    Primary 10860004894640