Devices

da Vinci Si" Surgical System

  • Modelo / Serial
    EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    EndoWrist Stapler 45 instrument for the da Vinci Si System || Model Number: IS3000 || Product Usage: || For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
  • Manufacturer
    Intuitive Surgical, Inc.
  • 1 Event

Fabricante

Intuitive Surgical, Inc.
  • Dirección del fabricante
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Empresa matriz del fabricante (2017)
    Intuitive Surgical Inc
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall IS3000 da Vinci Si" Surgical System
  • Modelo / Serial
    Product number 371683-05/Model Number VS3000 Serial numbers - USA: SH0018, SH0057, SH0097, SH0132, SH0165, SH0235, SH0019, SH0058, SH0098, SH0133, SH0167, SH0248, SH0021, SH0059, SH0099, SH0134, SH0168, USG015, SH0024, SH0060, SH0100, SH0135, SH0169, USG072, SH0025,SH0064, SH0101, SH0136, SH0170, USG146, SH0026, SH0065, SH0102, SH0137,SH0171, USG213, SH0029, SH0066, SH0103, SH0138, SH0172, USG317, SH0030, SH0067, SH0104, SH0139, SH0175, USG352, SH0031, SH0068, SH0105, SH0140, SH0177, USG353, SH0032, SH0069, SH0106 ,SH0141, SH0179 ,USG445, SH0033, SH0070, SH0107, SH0142, SH0180, USG519, SH0035, SH0071, SH0109, SH0143, SH0182, USG559, SH0036, SH0072, SH0110, SH0144, SH0184, USG631,SH0038, SH0073, SH0112, SH0145, SH0185, USG700, SH0039, SH0076, SH0113, SH0146, SH0186, USG701,SH0040, SH0077, SH0115, SH0147, SH0187, USG702, SH0041, SH0078, SH0117, SH0149, SH0188 ,USG703, SH0042, SH0079, SH0118, SH0150, SH0189, USG721, SH0044, SH0080, SH0119, SH0151, SH0190 ,USG728, SH0045, SH0081, SH0120, SH0152, SH0194, USG748, SH0046, SH0082, SH0121, SH0153, SH0196, USG750, SH0047, SH0085, SH0123, SH0154, SH020,2 USG764, SH0048, SH0088, SH0124, SH0155, SH0203, USG769, SH0050, SH0089, SH0125, SH0156, SH0204, USG770, SH0051 SH0090 SH0126 SH0157 SH0206 USG775, SH0052, SH0091, SH0127, SH0158, SH0211, USG786, SH0053, SH0092, SH0128, SH0159, SH0215,, USG787, SH0054, SH0094, SH0129, SH0160, SH0216, USG788, SH0055, SH0095, SH0130, SH0163, SH0223, SH0056, SH0096, SH0131, SH0164, SH0224, Out of US: SH0034,USG217, SH0086, SH0087, SH0028,SH0084,SH0111, SH0191, USG754, SH0114, SH0116, SH0063, SH0148, USG484, USG727, SH0161, SH0162, SH0061, SH0093, SH0238, USG726, SH0062, SH0037, USG806.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Belgium, France, Germany, Romania, India, Israel, Italy, South Korea, Norway, Slovak Republic, Spain, Sweden, Turkey, and United Kingdom.
  • Descripción del producto
    IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. || Product number 371683-05/Model Number VS3000 || The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and noncardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
  • Manufacturer
    Intuitive Surgical, Inc.