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Anovo RCUSS Fixator

FDA UDI

Class II (US FDA UDI)

by Momentis Surgical Ltd

Identity

Trade Name
Anovo RCUSS Fixator FDA UDI
Generic Name
Surgical instrument assist arm system, manually-adjusted 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 comprises Anovo Surgeon Console, two sterile instruments (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 Robotic Control Units are affixed firmly to the surgical bed via the Robotic Control Unit Support System (RCUSS), which includes the RCUSS Fixator (UDI # 07290018151112) and an Extension Rail (UDI # 07290018151129). The RCUSS Fixator is attached to the Robotic Control Units. The RCUSS Fixator can be attached to the surgical table directly or through the Extension Rail. 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 comprises Anovo Surgeon Console, two sterile instruments (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 Robotic Control Units are affixed firmly to the surgical bed via the Robotic Control Unit Support System (RCUSS), which includes the RCUSS Fixator (UDI # 07290018151112) and an Extension Rail (UDI # 07290018151129). The RCUSS Fixator is attached to the Robotic Control Units. The RCUSS Fixator can be attached to the surgical table directly or through the Extension Rail. FDA UDI

Identifiers

Catalog Number
AS-04-0058 FDA UDI
Primary DI / UDI-DI
07290018151112 FDA UDI
FDA Product Code
QNM FDA UDI
GMDN Term
Surgical instrument assist arm system, manually-adjusted 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

Category: Surgical instrument assist arm system, manually-adjusted

Anovo RCUSS Fixator by Momentis Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument assist arm system, manually-adjusted.

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 89cc1c3f-2887-443b-a9d0-4a9354077280 36 fields · synced May 30, 2026