AccessGUDID - DEVICE: Anovo ARMS Entry Guide (07290018151235)

GUDID

Device Identifier (DI) Information

Brand Name: Anovo ARMS Entry Guide
Version or Model: -
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MP-04-0569
Company Name: MOMENTIS SURGICAL LTD

Primary DI Number: 07290018151235
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600482439 *Terms of Use

Device Description: The AnovoTM 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 ARMS Entry Guide sealed with a disposable seal (gasket) when inserted into the Applied Medical GelPoint Mini Access Platform.

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?
32043	Laparoscopic surgical procedure kit, non-medicated, reusable	A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device.	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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0bf6d944-7b3c-4ac2-8bee-5091588c1307
Public Version Date: March 27, 2025
Public Version Number: 5
DI Record Publish Date: October 07, 2021