Anovo Cannula Short

Basic Information

• Brand Name: Anovo Cannula Short
• Primary DI: 07290018151211
• Version / Model: -
• Catalog Number: MP-04-0547
• Company Name: MOMENTIS SURGICAL LTD
• Labeler DUNS: 600482439
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-07
• Public Version: 4
• Public Version Date: 2022-07-29
• Public Version Status: Update
• Public Device Record Key: 848e863a-9ea4-4985-b302-d02786813c5b

Device Description

The Anovo 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 Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo 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 Anovo 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	878.4961	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37148	Laparoscopic access cannula, reusable	A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290018151218	GS1		1	In Commercial Distribution
Primary	07290018151211	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius