BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Teeth Screw Driver

    DI: 04719872108795 · Model: PN-2002 · ENTER MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Teeth Screw Driver
    Primary DI
    04719872108795
    Version / Model
    PN-2002
    Company Name
    ENTER MEDICAL CORPORATION
    Labeler DUNS
    658833116
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-19
    Public Version
    2
    Public Version Date
    2023-09-28
    Public Version Status
    Update
    Public Device Record Key
    9ab886ed-d2cc-43e5-95ce-d9da49a36e02

    Device Description

    A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    KBW Screw, Oral

    GMDN Terms

    Code Name
    16197 Mouth gag, non-adjustable

    Identifiers

    Type ID
    Primary 04719872108795