BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Intra-Lock

    DI: D742OPA20 · Model: OPA2 · INTRA-LOCK INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Intra-Lock
    Primary DI
    D742OPA20
    Version / Model
    OPA2
    Catalog Number
    OPA2
    Company Name
    INTRA-LOCK INTERNATIONAL, INC.
    Labeler DUNS
    131500998
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-11
    Public Version
    1
    Public Version Date
    2019-07-19
    Public Version Status
    New
    Public Device Record Key
    76878d69-fee5-4d81-b7d1-517b5b3640bd

    Device Description

    ONE PIECE™ IMPLANT ANALOG

    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
    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
    NDP Accessories, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    55847 Dental implant system

    Identifiers

    Type ID
    Primary D742OPA20