FDA UDI In Commercial Distribution 🇺🇸 United States

Anovo Unit Cable

DI: 07290018151051 · Model: - · MOMENTIS SURGICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Anovo Unit Cable
Primary DI
07290018151051
Version / Model
-
Catalog Number
FP-04-0004
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
4
Public Version Date
2022-07-29
Public Version Status
Update
Public Device Record Key
11604425-7fae-4c76-b8a2-7380402c46e6

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). Anovo Unit cables provide electrical connections and communication between a Robotic Control Unit and the Anovo Surgeon Console. There are two Unit cables, each connecting a single Robotic Control Unit to the Surgeon Console.

Device Characteristics

Single Use
No
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
QNM Mountable Electromechanical Surgical System For Transluminal Approaches

GMDN Terms

Code Name
58137 Endoscopic electromechanical surgical system

Identifiers

Type ID
Primary 07290018151051
Package 17290018151058

Customer Contacts

Phone
954-653-9210

Storage Conditions

Type
Handling Environment Humidity
Temperature Range
10 – 85 Percent (%) Relative Humidity
Type
Handling Environment Temperature
Temperature Range
0 – 50 Degrees Celsius
Type
Storage Environment Humidity
Temperature Range
10 – 85 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
0 – 50 Degrees Celsius