BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Single-use Biopsy Forceps

    DI: 06971381252200 · Model: BFTW-2311 · SCIVITA MEDICAL TECHNOLOGY CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Single-use Biopsy Forceps
    Primary DI
    06971381252200
    Version / Model
    BFTW-2311
    Company Name
    SCIVITA MEDICAL TECHNOLOGY CO., LTD.
    Labeler DUNS
    544519831
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-24
    Public Version
    1
    Public Version Date
    2023-06-01
    Public Version Status
    New
    Public Device Record Key
    45a4afc7-e5dd-4b60-bc7d-1c77742c66ad

    Device Description

    The single-use biopsy forceps has no physical or electrical connection to the endoscopic system and enters the human body through the instrument channel of the endoscope.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FCL Forceps, Biopsy, Non-Electric

    GMDN Terms

    Code Name
    38711 Flexible endoscopic biopsy forceps, single-use

    Identifiers

    Type ID
    Package 16971381252207
    Primary 06971381252200
    Package 26971381252204