AccessGUDID - DEVICE: Anovo Robotic Control Unit (07290018151310)

GUDID

Device Identifier (DI) Information

Brand Name: Anovo Robotic Control Unit
Version or Model: 20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP-02-0003
Company Name: MOMENTIS SURGICAL LTD

Primary DI Number: 07290018151310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600482439 *Terms of Use

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 procedures. The system comprises Anovo Surgeon Console, two sterile instruments (Instrument ARMS), Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Pedestal and Vaginal Access Kit). The Robotic Control Unit includes two Robotic Control Units permanently attached to each other by Momentis Surgical (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 Robotic Control Unit is mounted on the Pedestal.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58137	Endoscopic electromechanical surgical system	An assembly of mains electricity (AC-powered) electromechanical devices designed to be used to perform an endoscopic surgical procedure (e.g., laparoscopy) via hand-held rigid endoscopic instruments that have motor-driven articulating and mechanically-operated tips intended to facilitate surgical dexterity. It typically consists of a control unit that provides power via connecting cables to individual handpieces (handles) and several interchangeable endoscopic instruments with tip articulation (e.g., roll, yaw) for performing tissue manipulation, ligation, suturing, and cutting. The system is connected to a visual display unit (VDU) and is typically mounted on a trolley (cart) for mobility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65effc07-6ad9-49d7-9e4d-d8c94eb91a18
Public Version Date: June 19, 2025
Public Version Number: 3
DI Record Publish Date: March 11, 2025