Anovo RCUSS Fixator
Basic Information
- Brand Name
- Anovo RCUSS Fixator
- Primary DI
- 07290018151112
- Version / Model
- -
- Catalog Number
- AS-04-0058
- 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
- 89cc1c3f-2887-443b-a9d0-4a9354077280
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 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.
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
- No
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 |
|---|---|---|---|---|
| 62379 | Surgical instrument assist arm system, manually-adjusted | A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290018151119 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 07290018151112 | GS1 |
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