BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INFINTY EXTERNAL HEX SYSTEM

    DI: 00614950028597 · Model: 20COM0161 · ACE SURGICAL SUPPLY CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INFINTY EXTERNAL HEX SYSTEM
    Primary DI
    00614950028597
    Version / Model
    20COM0161
    Catalog Number
    20COM0161
    Company Name
    ACE SURGICAL SUPPLY CO., INC.
    Labeler DUNS
    042763706
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-16
    Public Version
    1
    Public Version Date
    2023-06-26
    Public Version Status
    New
    Public Device Record Key
    3eb0b4a1-990f-4158-88d0-65b4a7232f7b

    Device Description

    INTERNAL HEX SCANNING ABUTMENT. 4.5 MM PLAT ANT CH 13MM TITAN

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZE IMPLANT, ENDOSSEOUS, ROOT-FORM

    GMDN Terms

    Code Name
    55848 Screw endosteal dental implant, one-piece

    Identifiers

    Type ID
    Primary 00614950028597

    Customer Contacts

    Phone
    +1(508)588-3100 ext. 715
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K103790 000