BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Utility Center w/Arm

    DI: 00850043433460 · Model: P069201 · Engle Dental Systems, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Utility Center w/Arm
    Primary DI
    00850043433460
    Version / Model
    P069201
    Catalog Number
    P069201
    Company Name
    Engle Dental Systems, LLC
    Labeler DUNS
    039794292
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-09
    Public Version
    1
    Public Version Date
    2022-12-19
    Public Version Status
    New
    Public Device Record Key
    f9f75bed-93c5-425f-807d-5076ac6726ca

    Device Description

    Chair mounted utility center with telescopic arm

    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
    EIA Unit, Operative Dental

    GMDN Terms

    Code Name
    62725 Dental delivery system instrument unit, pneumatic

    Identifiers

    Type ID
    Primary 00850043433460

    Customer Contacts

    Phone
    (800)547-1906
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K983285 000