BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    A-dec

    DI: 10194665004491 · Model: 54.0877.00 · A-DEC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    A-dec
    Primary DI
    10194665004491
    Version / Model
    54.0877.00
    Catalog Number
    54.0877.00
    Company Name
    A-DEC, INC.
    Labeler DUNS
    009617473
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-07
    Public Version
    1
    Public Version Date
    2022-11-15
    Public Version Status
    New
    Public Device Record Key
    1a577857-6fe5-4985-a4c9-6427e883753d

    Device Description

    Air HS Package,E679L,Expert Torque,OTC

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EFB Handpiece, Air-Powered, Dental

    GMDN Terms

    Code Name
    64225 Pneumatic dental power tool system handpiece tip, reusable

    Identifiers

    Type ID
    Primary 10194665004491

    Premarket Submissions

    Submission Number Supplement Number
    K073478 000