BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00885556568125 · Model: 7205832F · 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
    00885556568125
    Version / Model
    7205832F
    Catalog Number
    7205832F
    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
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    2d09da7b-982f-4a73-80bd-f3f4e31d80e0
    Distribution End Date
    2022-03-17

    Device Description

    RFB INSUFFLATORDYONICS(R)

    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
    No

    Product Codes

    Code Name
    HIF INSUFFLATOR, LAPAROSCOPIC

    GMDN Terms

    Code Name
    48169 Insufflation gas conditioning system control unit

    Identifiers

    Type ID
    Primary 00885556568125

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K983326 000