ARTAS System ASY-45179

GUDID 00850470007012

RESTORATION ROBOTICS, INC.

Robotic surgical system
Primary Device ID00850470007012
NIH Device Record Keya1ff6266-86e1-4a7d-8fea-035c5b96a1ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameARTAS System
Version Model NumberChair
Catalog NumberASY-45179
Company DUNS627212587
Company NameRESTORATION ROBOTICS, 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 Datetrue
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
GS100850470007012 [Primary]

FDA Product Code

ONAComputer Assisted Hair Harvesting System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-15

On-Brand Devices [ARTAS System ]

00850470007029Accessories Kit
00850470007012Chair
90850470007008Cart

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.