BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00885556561218 · Model: 3628F · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    00885556561218
    Version / Model
    3628F
    Catalog Number
    3628F
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-28
    Public Version
    6
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    3e85cf3d-ea4c-4c13-958f-cade9c7867fd
    Distribution End Date
    2021-11-09

    Device Description

    RFB 4MM X 70 DEG X 35MM VAS

    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
    Yes
    Has Lot/Batch Number
    No
    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
    HRX ARTHROSCOPE

    GMDN Terms

    Code Name
    34856 Rigid optical arthroscope, reusable

    Identifiers

    Type ID
    Primary 00885556561218

    Customer Contacts

    Phone
    +1(800)238-7538
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K971253 000