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September 30, 2021

Package Declaration

Product Model: da Vinci® Surgical System, Model IS4000

The da Vinci Surgical System, Model IS4000 is a software-controlled, electromechanical system designed for
surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon
Console, a Patient Side Cart (PSC), a Vision Side Cart (VSC), and Endoscopes, Instruments and Accessories.

1. System carts

The products described below are provided for commercialization in palletized crates.

Model/ Part Number Product Name


SS4000/380677 Model IS4000 da Vinci Xi Surgical System - Surgeon Console
PS4000/380652 Model IS4000 da Vinci Xi Surgical System - Patient Cart
VS4000/381121 Model IS4000 da Vinci Xi Surgical System - Vision Cart
SS4000/380723 Model IS4000 da Vinci Xi Surgical System - Surgeon Console,
Reconditioned
VS4000/380721 Model IS4000 da Vinci Xi Vision System - Vision Console, Reconditioned
380620 da Vinci X Patient Cart

PRIMARIO: BOLSA / PELICULA DE RETENCION DE PLASTICO


SECUNDARIO: CAJA DE CARTON PALETIZADA

2. Instrument/Endoscope/Accessories Packaging

The Instrument/Endoscope/Accessories are provided for commercialization as described below:

Part Secondary
Product Name Primary package
Number package
342562 Instrument Introducer POLYETHYLENE CARTON BOX
Energy Activation Cable, Covidien, Force
371716 Triad PLASTIC LDPE CARTON BOX
371870 Energy Activation Cable, Ethicon PLASTIC LDPE CARTON BOX
372363 ASSY,SURGICAL SKILLS DRILL KIT POLY CARTON BOX
374480 Integrated Table Motion Upgrade Hardware PLASTIC LDPE CARTON BOX
377773 SimNow Simulator PLASTIC CARTON BOX
380225 da Vinci OnSite Wireless Option BUBBLE WRAP CARTON BOX
380989 Blue Fiber Cable Kit CARTON BOX N/A
381129 Blue Fiber Cable for Skills Simulator CARTON BOX N/A
381200 da Vinci Xi Accessory Starter Kit TYVEK+ NYLON CARTON BOX
SRK, EndoWrist Stapler Release Kit ,
381401 CARTON BOX N/A
Spanish
IRK, da Vinci Xi Instrument Release Kit,
381327 Spanish CARTON BOX N/A
381283 da Vinci X Accessory Starter Kit TYVEK+ NYLON CARTON BOX
400180 Tip Cover Accessory TYVEK CAJA DE
BOLSA/PELICULA DE CARTON
RETENCION DE PLASTICO
8mm Endoscope Washer/Disinfector
400482 POLYETHYLENE CARTON BOX
Connector Set
da Vinci Xi Endoscope Sterilization Tray
400490 POLY +FOAM CARTON BOX
(plastic)
da Vinci Xi Endoscope Sterilization Tray
400498 FOAM CARTON BOX
(stainless)
da Vinci Handheld Camera Sterilization Tray
400499 FOAM CARTON BOX
(stainless)
410370 EndoWrist Stapler Sheath CARTON BOX N/A
428064 5x300 mm Flexible Blunt Obturator POLY FILM CARTON BOX
428074 5x250 mm Flexible Blunt Obturator POLY FILM CARTON BOX
428076 10mm accessory cannula POLY FILM CARTON BOX
428084 10mm blunt obturator POLY FILM CARTON BOX
BOLSA/PELICULA CAJA DE
DE RETENCION DE CARTON
PLASTICO
470001 Potts Scissors CARTON BOX N/A
470002 8 mm Cannula POLY FILM CARTON BOX
470004 8 mm Cannula, Long POLY FILM CARTON BOX
470006 Large Needle Driver CARTON BOX N/A
470007 Round Tip Scissors CARTON BOX N/A
470008 8 mm Blunt Obturator POLY FILM CARTON BOX
470009 8 mm Blunt Obturator, Long POLY FILM CARTON BOX
470015 Arm Drape NYLON + TYVEK CARTON BOX
BOLSA PELICULA DE CAJA DE
RETENCION DE CARTON
PLASTICO

da Vinci Xi Endoscope with Camera, 8mm,


470026 LDPE + FOAM CARTON BOX

da Vinci Xi Endoscope with Camera, 8mm,


470027 LDPE + FOAM CARTON BOX
30˚
470033 Black Diamond Micro Forceps CARTON BOX N/A
470035 da Vinci Handheld Camera FOAM+ PLASTIC+ CARTON BOX
470036 DeBakey Forceps CARTON BOX N/A
470042 da Vinci Handheld Camera Light Guide E-FLUTE + FOAM CARTON BOX
470048 Long Tip Forceps CARTON BOX N/A
470049 Cadiere Forceps CARTON BOX N/A
da Vinci Handheld Camera Light Guide
470051 BUBBLE MAILER N/A
Adapter
da Vinci Endoscope Plus with Camera,
470056 LDPE + FOAM CARTON BOX
8mm, 0˚
da Vinci Endoscope Plus with Camera,
470057 LDPE + FOAM CARTON BOX
8mm, 30˚
470093 ProGrasp™ Forceps CARTON BOX N/A
470171 Micro Bipolar Forceps CARTON BOX N/A
470172 Maryland Bipolar Forceps CAJA DE CARTON N/A
470179 Hot Shears™ (Monopolar Curved Shears) CAJA DE CARTON N/A
470181 Resano Forceps CARTON BOX N/A
470183 Permanent Cautery Hook CARTON BOX N/A
CAJA DE CARTON
470184 Permanent Cautery Spatula CAJA DE CARTON N/A
470190 Cobra Grasper CARTON BOX N/A
470194 Mega Needle Driver CARTON BOX N/A
470205 Fenestrated Bipolar Forceps CAJA DE CARTON N/A
470207 Tenaculum Forceps CARTON BOX N/A
470215 Cardiac Probe Grasper CARTON BOX N/A
470230 Large Clip Applier CARTON BOX N/A
470246 Atrial Retractor Short Right CARTON BOX N/A
470249 Dual Blade Retractor CARTON BOX N/A
470296 Large SutureCut™ Needle Driver CARTON BOX N/A
470309 Mega SutureCut™ Needle Driver CARTON BOX N/A
470318 Small Graptor™ Grasping Retractor CARTON BOX N/A
470319 8 mm Cannula, Flared POLY FILM CARTON BOX
470327 Medium-Large Clip Applier CARTON BOX N/A
470341 Column Drape (Xi-only) TYVEK+ NYLON CARTON BOX
470344 Curved Bipolar Dissector CARTON BOX N/A
470347 Tip-Up Fenestrated Grasper CARTON BOX N/A
470359 8 mm Bladeless Obturator (Optical) SILICONE + TYVEK CARTON BOX
470360 8 mm Bladeless Obturator, Long (Optical) SILICONE + TYVEK CARTON BOX
BOLSA/ PELICULA DE CAJA DE
RETENCION DE CARTON
PLSATICO
470361 5 mm-8 mm Universal Seal (box of 10) CARTON BOX N/A
EndoWrist 12 mm & Stapler Cannula (100
470375 POLY FILM CARTON BOX
mm)
470376 EndoWrist 12 mm & Stapler Blunt Obturator POLY FILM CARTON BOX
470380 12 mm & Stapler Cannula Seal CARTON BOX N/A
470381 EndoWrist 12 - 8 mm Cannula Reducer CARTON BOX N/A
470383 Monopolar Energy Instrument Cord (13 ft.) PE BAG CARTON BOX
470384 Bipolar Energy Instrument Cord (17 ft.) PE BAG CARTON BOX
EndoWrist 12 mm & Stapler Cannula, Long
470389 POLY FILM CARTON BOX
(150 mm)
EndoWrist 12 mm & Stapler Blunt Obturator,
470390 POLY FILM CARTON BOX
Long
470395 12mm & Stapler Bladeless Obturator POLY FILM CARTON BOX
470396 12mm & Stapler Bladeless Obturator, Long POLY FILM CARTON BOX
470397 da Vinci Xi Gage Pin POLY FILM CARTON BOX
470398 8 mm Hasson Cone POLY FILM CARTON BOX
470399 12mm & Stapler Hasson Cone POLY FILM CARTON BOX
470400 Long Bipolar Grasper CARTON BOX N/A
470401 Small Clip Applier CARTON BOX N/A
470405 Force Bipolar Grasper CARTON BOX N/A
470443 EndoWrist Stapler Cannula Kit CARTON BOX N/A
SEAL,IS4000 PORTS,5MM-8MM,BOX OF
470500 TYVEK CARTON BOX
10
470629 Reprocessing Hardware Kit TUBING, POLYURETHANE CARTON BOX
478008 8mm blunt obturator POLY FILM CARTON BOX
478013 5mm Blunt Obturator POLY FILM CARTON BOX
478050 5 mm Maryland Dissector CARTON BOX N/A
600061 Firefly Imaging Upgrade N/A N/A
478053 5 mm Hem-O-Lok ML Clip Applier CARTON BOX N/A
478054 5 mm Suction Irrigator CARTON BOX N/A
478055 5 mm Cadiere Grasper CARTON BOX N/A
478057 5 mm Curved Scissors CARTON BOX N/A
478058 5 mm Fundus Grasper CARTON BOX N/A
478059 5 mm Crocodile Grasper CARTON BOX N/A
478060 5 mm Accessory Cannula POLY FILM CARTON BOX
478061 5x300 mm Curved Cannula, Camera Right POLY FILM CARTON BOX
478062 5x300 mm Curved Cannula, Camera Left POLY FILM CARTON BOX
478065 Single-Site Port (for 8.5mm Endoscope) POLY FILM CARTON BOX
478071 5x250 mm Curved Cannula, Camera Right POLY FILM CARTON BOX
478072 5x250 mm Curved Cannula, Camera Left POLY FILM CARTON BOX
478080 5 mm Maryland Bipolar Forceps FOAM CARTON BOX
478088 5mm Curved Needle Driver CARTON BOX N/A
478090 5 mm Permanent Cautery Hook CARTON BOX N/A
CARTON
478093 5 mm Fenestrated Bipolar Forceps PETG
BOX
600086 da Vinci OnSite Connectivity for Xi N/A N/A
478115 5 mm Wristed Needle Driver CARTON BOX N/A
478161 Xi SS Seal (Instruments + Camera) PET+ LDPE+ TYVEK CARTON BOX
478263 8mm Camera Cannula POLY FILM CARTON BOX
PETG+ SILICONE
480275 Xi Harmonic Ace (box of 6) CARTON BOX
COATED
CARTON
480299 Suction/Irrigator (box of 6) PETG
BOX
CARTON
480422 Vessel Sealer Extend (box of 6) FILM + TYVEK BOX
PETG+ SILICONE CARTON
480445 SureForm 45 (Box of 6)
COATED BOX
PETG+ SILICONE CARTON
480460 SureForm 60 (Box of 6)
COATED BOX
PETG+ SILICONE CARTON
480545 SureForm 45 Curve-Tip (Box of 6)
COATED BOX
950142 Replacement Audio Cable CARTON BOX N/A
381250-T IN-SERVICE KIT,STAPLER,IS4000 POLYURETHANE CARTON BOX
48345B SureForm 45 Blue Reload (box of 12) TYVEK CARTON BOX
48345G SureForm 45 Green Reload (box of 12) TYVEK CARTON BOX
48345M SureForm 45 Gray Reload (box of 12) TYVEK CARTON BOX
48345T SureForm 45 Black Reload (box of 12) TYVEK CARTON BOX
48345W SureForm 45 White Reload (box of 12) TYVEK CARTON BOX
48360B SureForm 60 Blue Reload (box of 12) TYVEK CARTON BOX
48360G SureForm 60 Green Reload (box of 12) TYVEK CARTON BOX
48360T SureForm 60 Black Reload (box of 12) TYVEK CARTON BOX
48360W SureForm 60 White Reload (box of 12) TYVEK CARTON BOX
471006 Large Needle Driver CARTON BOX N/A
471049 Cadiere Forceps CARTON BOX N/A
471093 ProGrasp Forceps CARTON BOX N/A
471172 Maryland Bipolar Forceps CARTON BOX N/A
471205 Fenestrated Bipolar Forceps CARTON BOX N/A
471309 Mega SutureCut Needle Driver CARTON BOX N/A
471405 Force Bipolar CARTON BOX N/A
471048 Long Tip Forceps CARTON BOX N/A
471171 Micro Bipolar Forceps CARTON BOX N/A
471190 Cobra Grasper CARTON BOX N/A
471296 Large SutureCut Needle Driver CARTON BOX N/A
471344 Curved Bipolar Dissector CARTON BOX N/A
471400 Long Bipolar Grasper CARTON BOX N/A
187513 Módulo de la interfaz de la mesa (TIM) CARTON BOX N/A

Sincerely,

Emilene Bertoldo Martins RA&QA


Manager, Latin America Intuitive

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