BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Insurgical, Inc.

    DI: 00860007230035 · Model: 320-0067-001 · Insurgical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Insurgical, Inc.
    Primary DI
    00860007230035
    Version / Model
    320-0067-001
    Catalog Number
    3010002
    Company Name
    Insurgical, Inc.
    Labeler DUNS
    078491571
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-17
    Public Version
    1
    Public Version Date
    2025-01-27
    Public Version Status
    New
    Public Device Record Key
    06ff6eca-5578-46ea-a3aa-74003afd15db

    Device Description

    Oscillating Saw Packaged Assembly

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

    GMDN Terms

    Code Name
    63566 Bone/joint surgical power tool motorized handpiece/set, electric, single-use

    Identifiers

    Type ID
    Primary 00860007230035