Anovo Blunt Cannula Obturator
Basic Information
- Brand Name
- Anovo Blunt Cannula Obturator
- Primary DI
- 07290018151198
- Version / Model
- -
- Catalog Number
- AS-04-0059
- 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
- efab9673-1279-4388-a9e7-6ef0b68092da
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 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).
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QNM | Mountable Electromechanical Surgical System For Transluminal Approaches | General, Plastic Surgery | 878.4961 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37151 | Laparoscopic access cannula dilator | A hollow dilator with a tapered distal end intended to enable the gentle insertion of a larger laparoscopic access cannula, necessary when significantly increasing the working access port's lumen, e.g., from 10 to 20 mm diameter. It is commonly used in minimally-invasive laparoscopic procedures. The dilator is entered over a guide rod, forcing a larger opening as the skin is pressed aside, thereby reducing the possible degree of damage. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018151198 | GS1 | ||||
| Package | 17290018151195 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 954-653-9210
- [email protected]
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