BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Obtura Spartan

    DI: 00816168020169 · Model: 930-115 · OBTURA SPARTAN ENDODONTICS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Obtura Spartan
    Primary DI
    00816168020169
    Version / Model
    930-115
    Catalog Number
    930-115
    Company Name
    OBTURA SPARTAN ENDODONTICS
    Labeler DUNS
    078371330
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-03
    Public Version
    4
    Public Version Date
    2022-09-27
    Public Version Status
    Update
    Public Device Record Key
    d5defac2-b9fd-41d0-a302-a8c172e6c2a7

    Device Description

    Tip Set CPR #1-5 Diamond Contains: 930-011 Tip CPR-1D Diamond DI# 00816168020244 930-012 Tip CPR-2D Diamond DI# 00816168020251 930-013 Tip CPR-3D Diamond DI# 00816168020268 930-014 Tip CPR-4D Diamond DI# 00816168020275 930-015 Tip CPR-5D Diamond DI# 00816168020282

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    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
    ELC Scaler, Ultrasonic

    GMDN Terms

    Code Name
    46035 Ultrasonic dental scaling/debridement system handpiece tip, endodontic

    Identifiers

    Type ID
    Primary 00816168020169