BEUDAMED
    FDA Registration Active 🇺🇸 United States

    C2Dx, Inc.

    Reg #: 3015489752 · FEI: 3015489752 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    C2Dx, Inc.
    Registration Number
    3015489752
    FEI Number
    3015489752
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    555 E Eliza St, Suite A
    City
    Schoolcraft
    State
    MI
    ZIP
    49087
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171764

    Owner / Operator

    Firm Name
    Critical Care Diagnostics, Inc
    Operator Number
    10059775
    Address
    555 E Eliza St
    City
    Schoolcraft
    State
    MI
    Postal Code
    49087
    Country
    US

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Laparoscope, General & Plastic Surgery GCJ
    Dilator, Catheter GCC
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Catheter, Drainage, Intraoral/Extraoral OAJ
    Pack, Hot Or Cold, Water Circulating ILO
    Monitor, Pressure, Intracompartmental LXC

    Proprietary Names

    Fixed Core Wire Guide Advance® Salivary Balloon Catheter with Wire Guide Salivary Access Dilator Set 7013-8050 HANDLE FOR MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM CONTROLLER; 7013-8400 MODEL P8400 HEMOSTATIX THERMAL 7013-5712 MODEL 5712 BLADE (QTY 24) FOR MODEL 600D, 2400Z, AND P8400 THERMAL SCALPEL SYSTEM CONTROLLERS; 7023-5712 MODEL 7013-5810 - Hemostatix Thermal System #10 Blade - Qty 24; 7013-5815 - Hemostatix Thermal Scalpel System #15 Blade - QTY NCircle® and NGage® Salivary Stone Extractor SialoCath® Salivary Duct Catheter Kolenda Salivary Access Introducer Set Mul T Pad T-Pump Temp Pump Pro Mul T Blanket T Pump STIC Intra-Compartmental Pressure Monitor System Shaw Thermal Scalpel System - SG6

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility