BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Flight Dental Systems

    DI: D884A12HP1000 · Model: A12H-100 · Flight Dental Systems
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Flight Dental Systems
    Primary DI
    D884A12HP1000
    Version / Model
    A12H-100
    Catalog Number
    A12 Operatory Package
    Company Name
    Flight Dental Systems
    Labeler DUNS
    241275150
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-22
    Public Version
    1
    Public Version Date
    2020-01-30
    Public Version Status
    New
    Public Device Record Key
    04d332cc-d981-447d-8f3b-e6187e8d6f20

    Device Description

    The A12 Operatory Package is a hydraulic dental chair with a radius swing mount delivery system. The dental chair features an ergonomic back and seat with synchronized movement. The chair also has the ability to rotate 30 degrees to the left and right.

    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 D884A12HP1000

    Premarket Submissions

    Submission Number Supplement Number
    K070196 000