BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Osteotomy Former

    DI: D7850470T0 · Model: 4.7mm Osteotomy Former · OCO BIOMEDICAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Osteotomy Former
    Primary DI
    D7850470T0
    Version / Model
    4.7mm Osteotomy Former
    Catalog Number
    0470T
    Company Name
    OCO BIOMEDICAL INC
    Labeler DUNS
    094146123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-22
    Public Version
    4
    Public Version Date
    2020-01-09
    Public Version Status
    Update
    Public Device Record Key
    f4634d8a-391f-4765-9cdc-b8463444c969

    Device Description

    4.7mm Osteotomy Former 4.7mm Diameter For placement of the 5mm ISI/TSI/ERI Mandibular Implant

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Serial Number
    Yes
    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
    DZA Drill, Dental, Intraoral

    GMDN Terms

    Code Name
    45714 Fixture/appliance dental drill bit, reusable

    Identifiers

    Type ID
    Primary D7850470T0