Hugo RAS

Basic Information

• Brand Name: Hugo RAS
• Primary DI: 10884521844575
• Version / Model: MRASI0001
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-02
• Public Version: 2
• Public Version Date: 2026-03-20
• Public Version Status: Update
• Public Device Record Key: 9d2a0833-579f-466c-96a2-45719a2dc235

Device Description

Monopolar Curved Shears

Device Characteristics

• Single Use: Yes
• 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
SCV	Modular electromechanical surgical system	General, Plastic Surgery	878.4964	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63111	Robotic electrosurgical instrument, monopolar, reusable	An electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a monopolar configuration (i.e., in conjunction with a separate return electrode) from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It includes a long thin body with a proximal housing intended to attach to the robotic arm, and may include the distal monopolar electrode in one of a variety of forms (e.g., forceps, hook). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521844575	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250725	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8mm;

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity