BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    AVD Transradial Access Drape

    DI: 10815614020446 · Model: 7100 · SEMLER TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AVD Transradial Access Drape
    Primary DI
    10815614020446
    Version / Model
    7100
    Catalog Number
    170-0100-01
    Company Name
    SEMLER TECHNOLOGIES, INC.
    Labeler DUNS
    042075700
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2023-07-04
    Public Version Status
    Update
    Public Device Record Key
    25c31c0b-034f-4cd8-9118-d9439c600ce8
    Distribution End Date
    2023-06-30

    Device Description

    Model 7100, Radial Drape, Single Hole

    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
    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
    PUI Drape, Surgical, Exempt

    GMDN Terms

    Code Name
    47783 Patient surgical drape, single-use

    Identifiers

    Type ID
    Primary 10815614020446
    Package 20815614020443