BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Endo Allis Forcep, 35cm with Ratchet and Rotate Handle

    DI: 10815288013751 · Model: EP3480RR · ENCISION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Endo Allis Forcep, 35cm with Ratchet and Rotate Handle
    Primary DI
    10815288013751
    Version / Model
    EP3480RR
    Catalog Number
    EP3480RR
    Company Name
    ENCISION, INC.
    Labeler DUNS
    612250175
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-31
    Public Version
    5
    Public Version Date
    2019-08-21
    Public Version Status
    Update
    Public Device Record Key
    edaeb0ca-9ef4-48d0-9b82-94c3fc1c5fe6
    Distribution End Date
    2018-09-21

    Device Characteristics

    Single Use
    No
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HET Laparoscope, Gynecologic (And Accessories)

    GMDN Terms

    Code Name
    35080 Rigid endoscopic tissue manipulation forceps, reusable

    Identifiers

    Type ID
    Primary 10815288013751

    Premarket Submissions

    Submission Number Supplement Number
    K925079 000

    Device Sizes

    Type Value Unit Text
    Length 35 Centimeter