BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NewGel+ Silicone Gel Sheeting

    DI: 00816465020350 · Model: NG-320 · Newmedical Technology, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NewGel+ Silicone Gel Sheeting
    Primary DI
    00816465020350
    Version / Model
    NG-320
    Company Name
    Newmedical Technology, Inc.
    Labeler DUNS
    787828669
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-07
    Public Version
    1
    Public Version Date
    2025-08-15
    Public Version Status
    New
    Public Device Record Key
    c89de669-e898-4672-b114-605dbc1dee85

    Device Description

    NG-320 NewGel+ Clear Silicone Areola, 2 7/8" dia. (7.2cm dia.), 2 pcs/package

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MDA Elastomer, Silicone, For Scar Management

    GMDN Terms

    Code Name
    44898 Scar-management dressing, reusable

    Identifiers

    Type ID
    Primary 00816465020350

    Customer Contacts

    Phone
    847-412-1000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K041704 000