BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DC-Air™ Holder Pack

    DI: 06429810587145 · Model: DC-HP-1 · Athlos Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DC-Air™ Holder Pack
    Primary DI
    06429810587145
    Version / Model
    DC-HP-1
    Company Name
    Athlos Oy
    Labeler DUNS
    368444471
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-10
    Public Version
    2
    Public Version Date
    2022-05-03
    Public Version Status
    Update
    Public Device Record Key
    6b842c88-6030-4ff6-b820-0106ed07e2a9

    Device Description

    DC-Air™ Holder Pack is intended to position and to hold x-ray sensor inside the mouth of the patient.

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EGZ Holder, Film, X-Ray

    GMDN Terms

    Code Name
    16205 Dental x-ray film holder, reusable
    31828 Dental x-ray system beam alignment device

    Identifiers

    Type ID
    Primary 06429810587145