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    FDA Registration Active 🇹🇷 Türkiye

    BURAK GLOBAL IC VE DIS TIC LTD STI

    Reg #: 3014461810 · FEI: 3014461810 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    86
    Establishment Types
    1
    Classifications
    50

    Registration Details

    Registration Name
    BURAK GLOBAL IC VE DIS TIC LTD STI
    Registration Number
    3014461810
    FEI Number
    3014461810
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Sahabiye Mh. Ahmet Pasa Cd., Ahmet Pasa Is Merk. No: 16/701
    City
    Kocasinan Kayseri
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K864102
    PMA Number
    P950022

    Owner / Operator

    Firm Name
    BURAK GLOBAL IC VE DIS TIC LTD STI
    Operator Number
    10058392
    Address
    Sahabiye Mh. Ahmet Pasa Cd., Ahmet Pasa Is Merk. No: 16/701
    City
    Kocasinan
    State
    Kayseri
    Postal Code
    38015
    Country
    TR
    Correspondent
    Hayati ERTUGRUL

    US Agent

    Business Name
    FDAbasics
    Contact Name
    Emily Matorin
    Address
    1 Prospect Park W Apt 4d
    City
    Brooklyn
    State
    NY
    ZIP
    11215
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Clip, Implantable FZP
    Endoscopic Tissue Approximation Device OCW
    Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects OXJ
    Mesh, Surgical, Polymeric FTL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Burst Suppression Detection Software For Electroencephalograph ORT
    Index-Generating Electroencephalograph Software OLW
    Reduced- Montage Standard Electroencephalograph OMC
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Applier, Surgical, Clip GDO
    Pneumoperitoneum Needle FHO
    Laparoscope, Gynecologic (And Accessories) HET
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Dressing, Wound, Drug FRO
    Protector, Ostomy EXE
    Staple, Implantable GDW
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Tube Tracheostomy And Tube Cuff JOH
    Laparoscope, General & Plastic Surgery GCJ
    Stapler, Surgical GAG
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Wire, Guide, Catheter DQX
    Mesh, Surgical FTM
    Permanent Defibrillator Electrodes NVY
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Laparoscope, General & Plastic Surgery, Reprocessed NLM
    Ring (Wound Protector), Drape Retention, Internal KGW
    Agent, Absorbable Hemostatic, Collagen Based LMF
    Catheter, Percutaneous DQY
    Catheter, Intravascular, Diagnostic DQO
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Silk GAP
    Suture, Absorbable, Natural GAL
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Syringe, Balloon Inflation MAV
    Insufflator, Hysteroscopic HIG
    Laryngoscope, Endoscope GCI
    Instrument, Ultrasonic Surgical LFL
    Forceps, Obstetrical HDA
    Instrument, Manual, Specialized Obstetric-Gynecologic KNA
    Suture, Absorbable, Synthetic GAN
    Motor, Surgical Instrument, Pneumatic Powered GET
    Agent, Absorbable Hemostatic, Non-Collagen Based LMG
    Tube, Tracheostomy (W/Wo Connector) BTO
    Transducer, Pressure, Catheter Tip DXO
    Catheter, Hemodialysis, Implanted, Coated NYU
    Catheter, Hemodialysis, Implanted MSD
    Razor, Surgical LWK

    Proprietary Names

    MCM20 Endo Stitch COMPOSITE MESH Ligasure Blunt Tip, Sealer/Divider, Nano-Coated Ligaclip Brain Monitoring Sensor Z304H & Z305H sutures LigaSure Maryland Jaw Sealer/Divider One-Step Sealing, Nano-Coated ENDO CLIP III5MM CLIP ADAPTER 120MM SURGINEEDLE INSUFFLATION NEEDLE polypropylene suture AQ Foam Adhesive Remover Spray Abstack30 MCP317H SR75 Open Fusion Laparoscopic Device AG SCD DRS Mesh Trach Tube Hemolok clip PREPERITONEAL DISTENTION BALLOON SYSTEM ENDOPATH Trocar Covidien EEA Stapler VERSAPORT V2 BLADELESS OPTIICAL TROCAR NC Trek Rx HI-TORQUE WHISPER ES GUIDE WIRE Endoscopic Linear Cutter EGIA Universal; Stapler PSD4506ECHV RETRIEVAL SYSTEM Pro Tack Fixation 5 mm Low Pressure Cuffed Trach Tube curved stapler Access and Dissector System Kii Balloon BluntTip 8556H DEFIBRILLATION LEAD Ethicon Clip Applier ONB Trocar Hemorrhoid and Prolapse Stapler Premium Plus CEEA Hemostat Flour Distal Access Catherer Vesaport Insufflation Needle SECURESTRAP 770G Analog Inflation Syringe SPACEMAKER SBT 10MM Guide wire Ligating Loop ONB Trocars Spacemaker Plus 2MM DILATOR & CANNULA ENDO CATCH GOLD 10MM HARH36 Bard Mesh SorbaFix and PermaFix Absorbable Fixation Systems Endoscopic Clamp V549G Wond Protector Surgical Mesh NC Trek Y493G 176645 Bard Arista AH 3g HARMONIC ACE LAPAROSCOPIC SHEARS 176643 EB230 Ligasure Sealer Divider Verrata PLUS Pressure Guide LAPAROSCOPIC SCISSOR MESH PERFIX PLUG PDP305H Stuturing Device HI-TORQUE GUIDE WIRE Endopath Ets-Flex45 Endoscopic Articulat Palindrome B11STS Clipper Blade Endo Clip Applier 5mm KII FIOS Linear cutter and selectable cartridges Self-Fixating Mesh Polyester

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device