BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZIEN MEDICAL TECHNOLOGIES LLC

    Reg #: 3009756153 · FEI: 3009756153 · Expires 2026
    View on FDA
    Products
    49
    Proprietary Names
    26
    Establishment Types
    3
    Classifications
    49

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    Registration Details

    Registration Name
    ZIEN MEDICAL TECHNOLOGIES LLC
    Registration Number
    3009756153
    FEI Number
    3009756153
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2490 South 300 West
    City
    Salt Lake City
    State
    UT
    ZIP
    84115
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231821

    Owner / Operator

    Firm Name
    Zien Medical Technologies LLC
    Operator Number
    10047676
    Address
    2490 South 300 West
    City
    Salt Lake City
    State
    UT
    Postal Code
    84115
    Country
    US
    Correspondent
    Tim Nieman

    Products

    Device Name Product Code
    Catheter, Continuous Flush KRA
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Tube, Aspirating, Flexible, Connecting BYY
    Catheter, Percutaneous DQY
    Catheter, Intravascular Occluding, Temporary MJN
    Catheter, Peripheral, Atherectomy MCW
    Scissors, Orthopedic, Surgical HRR
    Catheter And Tip, Suction JOL
    Continuous Measurement Thermometer FLL
    Cable, Electrode IKD
    Percutaneous Introducer Kit PXB
    Laryngoscope, Rigid CCW
    Tonometer, Manual HKY
    Needle, Hypodermic, Single Lumen FMI
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Catheter, Percutaneous, Cutting/Scoring PNO
    Probe HXB
    Instrument, Manual, Surgical, General Use MDM
    Template HWT
    Arthroscope HRX
    Syringe, Piston FMF
    Wire, Guide, Catheter DQX
    Catheter Introducer Kit OFC
    Laparoscope, General & Plastic Surgery GCJ
    Laparoscope, Gynecologic (And Accessories) HET
    Endoscope, Flexible GCQ
    Tray, Surgical LRP
    Tubing, Pressure And Accessories BYX
    Aspiration Thrombectomy Catheter QEZ
    Fiber, Medical, Absorbent FRL
    File, Bone, Surgical EMI
    Device, Intravascular Catheter Securement KMK
    Device, Irrigation, Ocular Surgery KYG
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Needle, Aspiration And Injection, Disposable GAA
    Accessories, Arthroscopic NBH
    Stethoscope, Electronic DQD
    Gauze / Sponge,Nonresorbable For External Use NAB
    Surgical Eye Tray PZG
    File HTP
    Knife, Orthopedic HTS
    Forceps HTD
    Rongeur HTX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Image Processing, Radiological LLZ
    Transducer, Ultrasonic, Diagnostic ITX
    Forceps, Rongeur, Surgical EMH

    Proprietary Names

    XC-BMC-30 Scissors CATS-L SAM IO XC-PRP-30 Probe Guideklip Template Arthroscope SPINR High-Performance Guidewire Controller Tray, Surgical Tubing CATS-D Tonometer Prism File, Bone, Surgical Morgan Lens Disposable Aspiration and Injection Needle Accessories, Arthroscopic Bone File Orthopedic Knife Forceps Rongeur Forceps Site-Rite® 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Technology Forceps, Rongeur, Surgical CATS Tonometer Prism ARX-LP6/ASPIRE RX-LP6 ASPIRATION CATHETER 136CM ASPIRE Mechanical Thrombectomy Aspirator/Drive Unit/Pump; ASPIRE RX-LP Rapid Exchange Mechanical Thrombectomy System

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility