BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Galaxy

    DI: 00190730009746 · Model: 88501 · ORTHO TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Galaxy
    Primary DI
    00190730009746
    Version / Model
    88501
    Company Name
    ORTHO TECHNOLOGY, INC.
    Labeler DUNS
    781772017
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-20
    Public Version
    5
    Public Version Date
    2021-09-21
    Public Version Status
    Update
    Public Device Record Key
    7963d1f6-8c3c-4391-a3a8-df7668e014db
    Distribution End Date
    2021-09-20

    Device Description

    Perforated Strips Wide Med 10/pk 3.75mm wide 45 micron

    Device Characteristics

    Single Use
    No
    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
    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
    No

    Product Codes

    Code Name
    EHM STRIP, POLISHING AGENT

    GMDN Terms

    Code Name
    63358 Dental abrasive strip, reusable

    Identifiers

    Type ID
    Primary 00190730009746