Hugo RAS

Sterile Monopolar Tip Cover

Registry build 21.09.26
1manufacturer
29catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code SCV
Manufacturer City Province Registered as Device types
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24

Record

Regulatory record for Hugo RAS
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 2025-12-23
Record revised 2026-03-20 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Special storage condition: Keep Dry; Storage environment temperature -22 to 140 °F; Handling environment temperature -30 to 60 °C; Storage environment humidity 15 to 85 % RH
Packaging Pack_or_inner_pack of 4, case of 2, case of 180, pack_or_inner_pack of 9, case of 3, pack_or_inner_pack of 20
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Hugo RAS
Catalogue number Size Status
MRASI0011 In distribution
MRASI0006 In distribution
MRASA0009 In distribution
MRASI0004 In distribution
MRASI0010 In distribution
MRASI0010 8mm; In distribution
MRASI0010 8mm; In distribution
MRASI0007 In distribution
MRASI0010 8mm; In distribution
MRASI0001 8mm; In distribution
MRASI0012 In distribution
MRASA0003 In distribution
MRASC0001 In distribution
MRASI0005 In distribution
MRASI0001 8mm; In distribution
MRASC0003 In distribution
MRASI0016 In distribution
MRASA0005 In distribution
MRASA0004 In distribution
MRASC0002 In distribution
MRASI0001 In distribution
MRASA0006 In distribution
MRASI0001 8mm; In distribution
MRASA0002 In distribution
MRASI0010 8mm; In distribution
MRASA0008 In distribution
MRASI0010 8mm; In distribution
MRASA0006 In distribution
MRASA0007 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Versius Visualisation Bedside Unit 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer