BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Shapleigh Ear Curette

    DI: 00192896115484 · Model: 467-4351 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Shapleigh Ear Curette
    Primary DI
    00192896115484
    Version / Model
    467-4351
    Catalog Number
    467-4351
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-29
    Public Version
    1
    Public Version Date
    2023-09-06
    Public Version Status
    New
    Public Device Record Key
    8762b4f2-724d-4643-959a-c7068a5f0e84

    Device Description

    Shapleigh Ear Curette Large Size Angled Serrated Tip Octagonal Handle

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    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
    ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    JYG CURETTE, EAR

    GMDN Terms

    Code Name
    47522 Endaural surgical curette, reusable

    Identifiers

    Type ID
    Primary 00192896115484

    Customer Contacts

    Phone
    +1(800)821-7496
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 6 Inch