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Anovo ARMS Entry Guide

FDA UDI

Class II (US FDA UDI)

by Momentis Surgical Ltd

Identity

Trade Name
Anovo ARMS Entry Guide FDA UDI
Generic Name
Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
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. FDA UDI
Model / Reference
- FDA UDI
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. FDA UDI

Identifiers

Catalog Number
MP-04-0569 FDA UDI
Primary DI / UDI-DI
07290018151235 FDA UDI
FDA Product Code
QNM FDA UDI
GMDN Term
Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4961 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Laparoscopic surgical procedure kit, non-medicated, reusable

Anovo ARMS Entry Guide by Momentis Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Momentis Surgical Ltd

Sources (1)

  • FDA UDI 0bf6d944-7b3c-4ac2-8bee-5091588c1307 36 fields · synced May 30, 2026