BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Excella III-D®

    DI: M711BTA1600 · Model: BTA-160 · Innovasis, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Excella III-D®
    Primary DI
    M711BTA1600
    Version / Model
    BTA-160
    Company Name
    Innovasis, Inc.
    Labeler DUNS
    156567492
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-07
    Public Version
    2
    Public Version Date
    2023-07-04
    Public Version Status
    Update
    Public Device Record Key
    94b382c0-dea6-4179-8af0-11a53ec2b771

    Device Description

    Al, SST, Silicone

    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
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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
    NKB Thoracolumbosacral Pedicle Screw System
    MNI Orthosis, Spinal Pedicle Fixation
    MNH Orthosis, Spondylolisthesis Spinal Fixation

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary M711BTA1600

    Customer Contacts

    Phone
    801-261-2236
    Email
    [email protected]