FDA.reportPublic FDA data

daVinci X

Primary DI
00886874115404
Brand
daVinci X
Company
INTUITIVE SURGICAL, INC.
Model
380620
Device description
PATIENT SIDE CART, 4-ARM
Published
2017-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NAYSystem,surgical,computer controlled instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAYSystem, Surgical, Computer Controlled InstrumentGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886874115404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886874115404008868741154048868741154040886874115404

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical telemanipulation systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a complete functional extension of the surgeon (master-stave telemanipulation) for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Regulatory Flags#

DUNS number
938647021
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886874116234Ion3807482019-03-21
00886874116241Ion3807072019-03-21
00886874110898daVinci Xi3811212016-07-08
00886874110720daVinci Xi3806522016-07-08
00886874110744daVinci Xi3806772016-07-08
00886874112298EndoWrist4701792016-07-08
00886874112342EndoWrist4701942016-07-08
00886874115374da Vinci Xi3807232017-11-01
00886874112366EndoWrist4702072016-07-08
00886874112120EndoWrist4700012016-07-08
00886874112168EndoWrist4700072016-07-08
00886874112229EndoWrist4700332016-07-08
00886874112236EndoWrist4700362016-07-08
00886874112304EndoWrist4701812016-07-08
00886874125663Force Feedback4773092026-03-26
00886874115732None4700422019-08-26
00886874112786None9510212016-07-08
00886874112793None9510262016-07-08
00886874115602None3130352017-07-12
00886874115954Flexision4901022019-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886874125618Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125625Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125632Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125649Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125656Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125663Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00815440022624SenhanceAsensus Surgical, Inc.NAY2026-03-09
00886874125946NoneINTUITIVE SURGICAL, INC.NAY2025-09-23
00886874125960NoneINTUITIVE SURGICAL, INC.NAY2025-09-23
10886874125974NoneINTUITIVE SURGICAL, INC.NAY2025-09-23
10886874125998NoneINTUITIVE SURGICAL, INC.NAY2025-09-23
00886874123188da Vinci SP Endoscope, 0°INTUITIVE SURGICAL, INC.NAY2025-09-04
00886874123362da Vinci EnergyINTUITIVE SURGICAL, INC.NAY2025-08-14
10886874123369da Vinci EnergyINTUITIVE SURGICAL, INC.NAY2025-08-14
00886874124598NoneINTUITIVE SURGICAL, INC.NAY2025-07-08
10886874124588NoneINTUITIVE SURGICAL, INC.NAY2025-07-08
00886874123645SureFormINTUITIVE SURGICAL, INC.NAY2025-06-20
00886874123652SureFormINTUITIVE SURGICAL, INC.NAY2025-06-20
10886874123659SureFormINTUITIVE SURGICAL, INC.NAY2025-06-20
00886874125854NoneINTUITIVE SURGICAL, INC.NAY2025-04-16
00886874125915NoneINTUITIVE SURGICAL, INC.NAY2025-04-16
00886874125922NoneINTUITIVE SURGICAL, INC.NAY2025-04-16
00886874125939NoneINTUITIVE SURGICAL, INC.NAY2025-04-16
00886874125557Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125564Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125571Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125595Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125601Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125588Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00815440022266SenhanceAsensus Surgical, Inc.NAY2025-01-14