AnovoTM Instrument ARMS

Basic Information

• Brand Name: AnovoTM Instrument ARMS
• Primary DI: 17290018151096
• Version / Model: -
• Catalog Number: FP-01-0001
• 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: 6
• Public Version Date: 2022-07-29
• Public Version Status: Update
• Public Device Record Key: c1e91172-4c71-4d0a-a91e-2d0c2573e7bc

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 Anovo Instrument ARMS are the system’s components that are inserted transvaginally into the pelvic cavity to manipulate the tissue and perform the surgery. Two identical Instrument ARMS are connected to the Robotic Control Units, each of which corresponds to the respective hand of the surgeon as controlled by right or left Controllers. The two Arms utilized with the Anovo System are identical and provide identical capabilities. The end effector, located at the end of the flexible section, provides grasping and electrosurgical capabilities. The Instrument Arm is a sterile disposable component. It is ETO sterilized and provided to the user within a plastic tray packaged in a sterile pouch. Instrument ARMS Packed with Cannula Seal & ARMS Entry Guide Seal

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
65882	Robotic electrosurgical instrument, bipolar/monopolar	An electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in both a bipolar and monopolar configuration from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It includes a long thin body with a proximal housing intended to attach to the robotic arm, and includes the distal bipolar/monopolar electrodes in a variety of forms (e.g., forceps, hook, tip). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290018151096	GS1
Package	27290018151093	GS1		10	In Commercial Distribution

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