Hugo RAS

Basic Information

• Brand Name: Hugo RAS
• Primary DI: 10884521851085
• Version / Model: MRASA0009
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-24
• Public Version: 5
• Public Version Date: 2026-03-20
• Public Version Status: Update
• Public Device Record Key: c9abbc20-dab1-4fbb-a6cc-ea60e009aae2

Device Description

Sterile Monopolar Tip Cover

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521851085	GS1
Package	30884521851089	GS1	CASE	180	In Commercial Distribution
Package	20884521851082	GS1	PACK_OR_INNER_PACK	9	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K250725	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit