Hominis® Robotic Control Unit (RCU) FP-02-0003

GUDID 07290018151044

The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system comprises Hominis Surgeon Console, two sterile instruments (Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Hominis System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Robotic Control Unit includes two Robotic Control Units permanently attached to each other by Memic (cannot be separated by user). Robotic Control Unit contains brushed motors, sensors, drivers and the electronic board required to drive the Instrument ARMS. Each Robotic Control Unit drives one Arm. The two Robotic Control Units are mirrored and identical except for that the right Robotic Control Unit (RCU I) includes an adaptor that enables mounting of the Robotic Control Units Assembly to the Robotic Control Support System and a mechanism that controls the linear movement of the Robotic Control Units and Instrument ARM. The Robotic Control Units connect the Instrument ARMS to an electrosurgical generator.

MEMIC INNOVATIVE SURGERY LTD

Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system
Primary Device ID07290018151044
NIH Device Record Keyb77cc7aa-245a-4154-a87d-96b38e25639d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHominis® Robotic Control Unit (RCU)
Version Model Number-
Catalog NumberFP-02-0003
Company DUNS600482439
Company NameMEMIC INNOVATIVE SURGERY LTD
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

Customer Support Contacts

Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com
Phone954-653-9210
Emailcustomerservice@memicmed.com

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290018151044 [Primary]
GS117290018151041 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QNMMountable Electromechanical Surgical System For Transluminal Approaches

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-15
Device Publish Date2021-10-07

Devices Manufactured by MEMIC INNOVATIVE SURGERY LTD

07290018151013 - Hominis® Surgeon Console2021-10-15 The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic ma
17290018151034 - Hominis® Power Cable2021-10-15 The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic ma
07290018151044 - Hominis® Robotic Control Unit (RCU)2021-10-15The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system comprises Hominis Surgeon Console, two sterile instruments (Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Hominis System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Robotic Control Unit includes two Robotic Control Units permanently attached to each other by Memic (cannot be separated by user). Robotic Control Unit contains brushed motors, sensors, drivers and the electronic board required to drive the Instrument ARMS. Each Robotic Control Unit drives one Arm. The two Robotic Control Units are mirrored and identical except for that the right Robotic Control Unit (RCU I) includes an adaptor that enables mounting of the Robotic Control Units Assembly to the Robotic Control Support System and a mechanism that controls the linear movement of the Robotic Control Units and Instrument ARM. The Robotic Control Units connect the Instrument ARMS to an electrosurgical generator.
07290018151044 - Hominis® Robotic Control Unit (RCU)2021-10-15 The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic ma
07290018151051 - HOMINIS® Unit Cable2021-10-15 The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic ma
17290018151119 - Hominis® RCUSS Fixator2021-10-15 The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic ma
17290018151126 - Hominis® RCUSS Extension Rail2021-10-15 The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic ma
17290018151133 - HOMINIS® Sterile Drape for Robotic Control Unit, bottom2021-10-15 The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic ma
17290018151140 - Hominis® Sterile Drape for Robotic Control Unit, top2021-10-15 The Hominis® Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic ma

Trademark Results [Hominis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HOMINIS
HOMINIS
79199482 5197920 Live/Registered
MEMIC INNOVATIVE SURGERY LTD.
2016-08-23

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