FDA.reportPublic FDA data

Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile

Primary DI
00850470007364
Brand
Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile
Company
RESTORATION ROBOTICS, INC.
Model
18G 2 Prong
Published
2018-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K103428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103428000THE ARTAS SYSTEM FROM RESTORATION ROBOTICSRestoration Robotics, Inc.2011-04-04ONA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850470007364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850470007364008504700073648504700073640850470007364

GMDN Terms#

Term, Definition table
TermDefinition
Hair extraction punchA hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract small plugs of donor skin containing hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
627212587
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90850470007008ARTAS System CartFP-400002016-08-15
00850470007012ARTAS System ChairASY-451792016-08-15
00850470007029ARTAS SystemAccessories KitFP-260002016-08-15
00850470007531ARTAS iXChairFP-470002018-11-12
00850470007524ARTAS iX SystemFP-450002018-11-12
00850470007562Disposable Kit, Sterile and Non Sterile, iX 18G 4 ProngFP-1027682018-11-12
00850470007579Disposable Kit, Sterile and Non Sterile, iX 19G 4 ProngFP-1027692018-11-12
00850470007623Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX18GFP-1027772018-11-12
00850470007630Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX19GFP-1027782018-11-12
00850470007371Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile18G 4 Prong2018-03-07
00850470007388Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile19G 2 Prong2018-03-07
00850470007395Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile19G 4 Prong2018-03-07
00850470007401Disposable Kit, Sterile (S)18G 2 Prong2018-03-07
00850470007425Disposable Kit, Sterile (S)19G 2 Prong2018-03-07
00850470007432Disposable Kits, Sterile and Non-Sterile (S)19G 2 Prong2018-03-07
00850470007449Disposable Kit, Sterile (S)20G 2 Prong2018-03-07
00850470007456Disposable Kits, Sterile and Non-Sterile (S)20G 2 Prong2018-03-07
00850470007463Disposable Kit, Sterile (S)18G 4 Prong2018-03-07
00850470007470Disposable Kits, Sterile and Non-Sterile (S)18G 4 Prong2018-03-07
00850470007487Disposable Kit, Sterile (S)19G 4 Prong2018-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060830079ARTAS SystemVenus Concept Inc.ONA2023-06-08
00810060831632ARTAS iX Venus Concept Inc.ONA2018-11-12
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
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