BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Soft-Form™ ALD External Nasal Splint

    DI: 00818501022519 · Model: 20-10310 · INVOTEC INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Soft-Form™ ALD External Nasal Splint
    Primary DI
    00818501022519
    Version / Model
    20-10310
    Catalog Number
    20-10310
    Company Name
    INVOTEC INTERNATIONAL, INC.
    Labeler DUNS
    622812592
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-06
    Public Version
    1
    Public Version Date
    2022-12-14
    Public Version Status
    New
    Public Device Record Key
    173eb45f-ca46-439e-a155-6024c4e1776a

    Device Description

    Soft-Form™ ALD External Nasal Splint, Regular

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Serial Number
    No
    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
    EPP Splint, Nasal

    GMDN Terms

    Code Name
    35411 External nasal splint

    Identifiers

    Type ID
    Package 10818501022516
    Primary 00818501022519
    Package 20818501022513