BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Surgical Direct

    DI: B382SD1313890 · Model: SD131389 · Surgical Direct, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Surgical Direct
    Primary DI
    B382SD1313890
    Version / Model
    SD131389
    Catalog Number
    SD131389
    Company Name
    Surgical Direct, Inc.
    Labeler DUNS
    124367223
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-27
    Public Version
    1
    Public Version Date
    2023-11-06
    Public Version Status
    New
    Public Device Record Key
    0c95da17-b85d-4fe1-be5a-0814fe01f905

    Device Description

    2.9mm 20cm Miniature Johan Grasper Forceps, Single Action, With Flush Port Sheath

    Device Characteristics

    Single Use
    No
    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
    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
    33199 Flexible endoscopic tissue manipulation forceps, single-use

    Identifiers

    Type ID
    Primary B382SD1313890

    Customer Contacts

    Phone
    +1(386) 738-1202
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K974382 000