Hominis® Cannula Short MP-04-0547

GUDID 17290018151218

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 composed of Hominis Surgeon Console, two sterile instruments (Hominis 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 Vaginal Access Kit (UDI # 27290018151154) contains several accessories which facilitate insertion of the Hominis Instrument ARMS® transvaginally. The kit contains: Cannula Connector, Cannula (Short and long), Cannula Obturator Needle, ARMS Entry Guide, Blunt Cannula Obturator, Mini Introducer, Vaginal Access Fixator (includes attached Guiding Rail), Cannula Seal Extraction Tool and seals (Cannula Seal and ARMS Entry Guide Seal). The cannula sealed with a disposable seal (gaskets) when inserted into the Applied Medical GelPoint Mini Access Platform.

MEMIC INNOVATIVE SURGERY LTD

Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable
Primary Device ID17290018151218
NIH Device Record Key848e863a-9ea4-4985-b302-d02786813c5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHominis® Cannula Short
Version Model Number-
Catalog NumberMP-04-0547
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
GS107290018151211 [Primary]
GS117290018151218 [Package]
Contains: 07290018151211
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 Usetrue
Device Is Sterilefalse

[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


[17290018151218]

Moist Heat or Steam Sterilization


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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