BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SCANLAN® Minimally-Invasive Instrumentation

    DI: 00846159034769 · Model: 9009-285 · SCANLAN INTERNATIONAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SCANLAN® Minimally-Invasive Instrumentation
    Primary DI
    00846159034769
    Version / Model
    9009-285
    Catalog Number
    9009-285
    Company Name
    SCANLAN INTERNATIONAL INC
    Labeler DUNS
    023055619
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-30
    Public Version
    2
    Public Version Date
    2019-08-21
    Public Version Status
    Update
    Public Device Record Key
    db0b344d-479e-4299-b56e-01d23d33a2ef

    Device Description

    SCANLAN® Minimally-Invasive Dissector

    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
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    35080 Rigid endoscopic tissue manipulation forceps, reusable

    Identifiers

    Type ID
    Primary 00846159034769

    Customer Contacts

    Phone
    651-297-0997
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K945474 000