BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Baby Gorilla®/Gorilla® Plating System

    DI: 00889795149978 · Model: P99-931-0008-SK · Paragon 28, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Baby Gorilla®/Gorilla® Plating System
    Primary DI
    00889795149978
    Version / Model
    P99-931-0008-SK
    Catalog Number
    P99-931-0008-SK
    Company Name
    Paragon 28, Inc.
    Labeler DUNS
    042961576
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-06
    Public Version
    1
    Public Version Date
    2025-11-14
    Public Version Status
    New
    Public Device Record Key
    799c4ec5-61be-4686-ae0d-dbe1eeda9d19

    Device Description

    Bone Graft Harvester, 8mm Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    LXH Orthopedic manual surgical instrument

    GMDN Terms

    Code Name
    17131 Orthopaedic surgery tissue debris collector, single-use

    Identifiers

    Type ID
    Primary 00889795149978