Hominis® Robotic Control Unit Support System (RCUSS) FP-04-0005

GUDID 27290018151109

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) Hominis System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Robotic Control Units are affixed firmly to the surgical bed via the Robotic Control Unit Support System, which includes the RCUSS Fixator (UDI # 07290018151112) and an Extension Rail (UDI # 07290018151129). The RCUSS Fixator is attached to the Robotic Control Units. The RCUSS Fixator can be attached to the surgical table directly or through the Extension Rail.

MEMIC INNOVATIVE SURGERY LTD

Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted
Primary Device ID27290018151109
NIH Device Record Key068d6a1e-fb7e-4773-9a8f-5a6783df8d5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHominis® Robotic Control Unit Support System (RCUSS)
Version Model Number-
Catalog NumberFP-04-0005
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
GS127290018151109 [Primary]

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)2021-10-15 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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