BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SCAN ADAPTER

    DI: D78532530SA0 · Model: 3.25MM ENGAGE PEEK SCAN ADAPTER · OCO BIOMEDICAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SCAN ADAPTER
    Primary DI
    D78532530SA0
    Version / Model
    3.25MM ENGAGE PEEK SCAN ADAPTER
    Catalog Number
    32530 SA
    Company Name
    OCO BIOMEDICAL INC
    Labeler DUNS
    094146123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-12
    Public Version
    2
    Public Version Date
    2025-02-06
    Public Version Status
    Update
    Public Device Record Key
    55c633a7-b673-434a-a336-f86859d92f5a

    Device Description

    3.25MM ENGAGE PEEK SCAN ADAPTER

    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
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    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
    NDP Accessories, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    61641 Dental implant abutment analog, intraoral-scanning, single-use

    Identifiers

    Type ID
    Primary D78532530SA0