daVinci Xi

GUDID 00886874110898

VISION SIDE SYSTEM

INTUITIVE SURGICAL, INC.

Robotic surgical system
Primary Device ID00886874110898
NIH Device Record Key7a0204c4-5d3d-4e6f-bf65-0d43599fef9f
Commercial Distribution StatusIn Commercial Distribution
Brand NamedaVinci Xi
Version Model Number381121
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
GS100886874110898 [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 Number40
Public Version Date2020-05-05
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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