daVinci Xi

GUDID 00886874110744

SURGEON SIDE CONSOLE, SMART PEDALS

INTUITIVE SURGICAL, INC.

Robotic surgical system
Primary Device ID00886874110744
NIH Device Record Key81ef9c10-03ce-45b0-a831-e3edd99ed741
Commercial Distribution StatusIn Commercial Distribution
Brand NamedaVinci Xi
Version Model Number380677
Company DUNS938647021
Company NameINTUITIVE SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100886874110744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NAYSystem,surgical,computer controlled instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number42
Public Version Date2020-05-07
Device Publish Date2016-07-08

On-Brand Devices [daVinci Xi]

00886874115510VISION SIDE SYSTEM, RECERTIFIED
00886874115503SURGEON SIDE CONSOLE, RECERTIFIED
00886874115497PATIENT SIDE CART, RECERTIFIED
00886874110898VISION SIDE SYSTEM
00886874110744SURGEON SIDE CONSOLE, SMART PEDALS
00886874110720PATIENT SIDE CART, 4-ARM

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