BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ORTA MEDICAL LTD

    Reg #: 3013188547 · FEI: 3013188547 · Expires 2026
    View on FDA
    Products
    100
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    100

    Registration Details

    Registration Name
    ORTA MEDICAL LTD
    Registration Number
    3013188547
    FEI Number
    3013188547
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BAZELET 14
    City
    TZUR YIGAL Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K081169

    Owner / Operator

    Firm Name
    ORTA MEDICAL LTD
    Operator Number
    10053784
    Address
    BAZELET 14
    City
    ZUR IGAL
    State
    IL-NOTA
    Postal Code
    44862
    Country
    IL

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, Irrigation, Urological LJH
    Arthroscope HRX
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Stapler, Surgical GAG
    Container, Liquid Medication, Graduated KYW
    Electrode, Electrocardiograph DRX
    Oximeter, Ear DPZ
    Oximeter DQA
    System, Thermal Regulating DWJ
    Dropper, Ent KCM
    System, Surgical, Computer Controlled Instrument NAY
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Set, Administration, Intravascular FPA
    Accessories, Cleaning Brushes, For Endoscope MNL
    Esthesiometer GXB
    Tube, Aspirating, Flexible, Connecting BYY
    Ophthalmoscope, Ac-Powered HLI
    Electrode, Electrosurgical JOS
    Instrument, Ultrasonic Surgical LFL
    Bandage, Liquid KMF
    Automated Urinalysis System KQO
    Clip, Implantable FZP
    Applier, Surgical, Clip GDO
    Container, Specimen Mailer And Storage, Temperature Controlled, Sterile KDW
    Scalpel, One-Piece GDX
    Gag, Mouth KBN
    Set, I.V. Fluid Transfer LHI
    Tissue Adhesive For The Topical Approximation Of Skin MPN
    Dressing, Wound, Drug FRO
    Staple, Implantable GDW
    Syringe, Balloon Inflation, Exempt PTM
    Mesh, Surgical, Polymeric FTL
    Device, Fixation, Tracheal Tube CBH
    Scissors, Medical, Disposable JOK
    Tube Tracheostomy And Tube Cuff JOH
    Stent, Vaginal KXP
    Gas-Machine, Anesthesia BSZ
    Laparoscope, General & Plastic Surgery, Reprocessed NLM
    Cannula, A-V Shunt FIQ
    Anti Fog Solution And Accessories, Endoscopy OCT
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Cannula, Nasal, Oxygen CAT
    Tube, Tracheal (W/Wo Connector) BTR
    Sterilant, Medical Devices MED
    Staple, Removable (Skin) GDT
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI
    Spirometer, Diagnostic BZG
    Polymer Patient Examination Glove LZA
    Non-Surgical Gown OEA
    Support, Breathing Tube JAY
    Cutaneous Tissue Adhesive With Mesh OMD
    Drape, Surgical, Antimicrobial KKX
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Tubing, Pressure And Accessories BYX
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
    Introducer, Syringe Needle KZH
    Endoscopic Tissue Approximation Device OCW
    Device, Medical Examination, Ac Powered KZF
    Mesh, Surgical, Deployer ORQ
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Support, Patient Position CCX
    Clip, Nose BXJ
    Catheters, Suction, Tracheobronchial BSY
    Tube, Tracheostomy (W/Wo Connector) BTO
    Device, Intravascular Catheter Securement KMK
    Syringe, Irrigating (Non Dental) KYZ
    Dispenser, Liquid Medication KYX
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Tape And Bandage, Adhesive KGX
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Stopcock, I.V. Set FMG
    Culture Media, Non-Propagating Transport JSM
    Stylet, Tracheal Tube BSR
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Apparatus, Exhaust, Surgical FYD
    Otoscope ERA
    Instrument, Biopsy KNW
    Forceps HTD
    Gauze / Sponge,Nonresorbable For External Use NAB
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Pneumoperitoneum Needle FHO
    Pad, Neonatal Eye FOK
    Disinfectant, Medical Devices LRJ
    Electrocardiograph DPS
    Container, I.V. KPE
    Test, Time, Prothrombin GJS
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Prosthesis, Laryngeal (Taub) EWL
    Catheter And Tip, Suction JOL
    Tubes, Gastrointestinal (And Accessories) KNT
    Tube, Laryngectomy KAC
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    System, Blood Culturing MDB
    Instrument, Manual, Surgical, General Use MDM

    Proprietary Names

    ORTA MEDICAL SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID URISCREEN 6L STRIP 10S URISCAN 10 SGL STRIP 774 UNISCAN 10 SGL STRIP 10 S ENDO CATCH GOLD Verastep Laparoscope, general & plastic surgery VERASTEP shiley covidian Ophthalmoscope, ac-powered Non-surgical isolation gown hylard Device, medical examination, ac powered Shiley Disposable Cannula Trach. Tube LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated Shiley ERA - OTOSCOPE Gauze / sponge,nonresorbable for external use SPIROMETER, DIAGNOSTIC DPS - Electrocardiograph Owen Mumford

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device