Hugo
System Prep & Pack User Guides (EN)
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | SCV |
| Device type | Modular Electromechanical Surgical System |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4964 |
| 510(k) | K250725 |
| Record published | 2025-12-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 15 to 85 % RH; Handling environment temperature -22 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MRASM002E | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hugo RAS | Covidien LP | 29 |
| Versius Monopolar Bedside Unit Cable | CMR Surgical Limited | 1 |
| Versius Bedside Unit Cable (Short) | CMR Surgical Limited | 1 |
| Versius Instrument Bedside Unit | CMR Surgical Limited | 1 |
| Versius Insulating Sleeve Accessory → Carton Pack (Qty 12 x 10021), 10022 | CMR Surgical Limited | 1 |
| Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippe | CMR Surgical Limited | 1 |
| Versius Surgeon Console | CMR Surgical Limited | 1 |
| Versius Bipolar Bedside Unit Cable | CMR Surgical Limited | 1 |
| Versius Bipolar Fenestrated Grasper | CMR Surgical Limited | 1 |
| Versius Endoscope 0° (vLimeLite) | CMR Surgical Limited | 1 |
| Versius Camera Head (compatible with vLimeLite) | CMR Surgical Limited | 1 |
| Versius Fenestrated Grasper | CMR Surgical Limited | 1 |
Showing 12 of 24. All products under Modular Electromechanical Surgical System
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.