FDA.reportPublic FDA data

ARTAS iX

Primary DI
00810060831632
Brand
ARTAS iX
Company
Venus Concept Inc.
Model
System
Catalog number
FP-45000
Published
2018-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ONAComputer Assisted Hair Harvesting System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONAComputer Assisted Hair Harvesting SystemNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173358000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173358000ARTAS SystemRestoration Robotics, Inc.2018-03-16ONA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060831632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060831632008100608316328100608316320810060831632

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical arm systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117333774
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810060832851Venus NovaFP-20012026-04-15
00810060831359Venus Versa PROVE1024082026-04-15
00810060830079ARTAS SystemFP-250002023-06-08
00810060830444Venus BlissBL0000012023-06-08
00810060830628Venus Viva VI102402GLB2023-06-08
00810060830680Venus VersaVE1024072023-06-08
00810060830826Venus Legacy (100V)LE1000042023-06-08
00810060830833Venus Legacy (120V)LE1200042023-06-08
00810060830840Venus Legacy (240V) LE2400042023-06-08
00810060830574Venus VelocityVL0000012023-06-08
00810060830987Venus Bliss MaxBLMX00012023-06-08
00810060831250Venus AIME FP-600002023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060830079ARTAS SystemVenus Concept Inc.ONA2023-06-08
00850470007524ARTAS iX RESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007531ARTAS iXRESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007562Disposable Kit, Sterile and Non Sterile, iX RESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007579Disposable Kit, Sterile and Non Sterile, iX RESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007623Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iXRESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007630Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iXRESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007364Disposable Kit, Punch and Needle Assembly, 5 Pack SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007371Disposable Kit, Punch and Needle Assembly, 5 Pack SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007388Disposable Kit, Punch and Needle Assembly, 5 Pack SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007395Disposable Kit, Punch and Needle Assembly, 5 Pack SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007401Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007418Disposable Kits, Sterile and Non-SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007425Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007432Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007449Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007456Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007463Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007470Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007487Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007494Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007500Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007517Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007289Disposable Kit, 20G SterileRESTORATION ROBOTICS, INC.ONA2017-01-31
00850470007296Disposable Kits, 20G RESTORATION ROBOTICS, INC.ONA2017-01-31
00850470007302Disposable Kit, 20G SterileRESTORATION ROBOTICS, INC.ONA2017-01-31
00850470007319Disposable Kits, 20GRESTORATION ROBOTICS, INC.ONA2017-01-31
00850470007326Disposable KitRESTORATION ROBOTICS, INC.ONA2016-09-08
00850470007333Disposable KitRESTORATION ROBOTICS, INC.ONA2016-09-08
00850470007340Disposable KitsRESTORATION ROBOTICS, INC.ONA2016-09-08