BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Redi-Lock™

    DI: 00190707193201 · Model: 501-003U-S · Ortho Organizers, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    Redi-Lock™
    Primary DI
    00190707193201
    Version / Model
    501-003U-S
    Company Name
    Ortho Organizers, Inc.
    Labeler DUNS
    062165188
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2025-10-23
    Public Version
    3
    Public Version Date
    2025-12-30
    Public Version Status
    Update
    Public Device Record Key
    71f8eb3d-2bba-4b22-805d-bd12f5c57127

    Device Description

    REDI-LOCK IMPRESSION TRAYS PEDO LARGE UPPER-BLUE 50PK

    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
    No

    Product Codes

    Code Name
    EHY TRAY, IMPRESSION, PREFORMED

    GMDN Terms

    Code Name
    16350 Dental impression tray, single-use

    Identifiers

    Type ID
    Unit of Use 10190707193208
    Primary 00190707193201