Hugo RAS

Basic Information

• Brand Name: Hugo RAS
• Primary DI: 10884521851023
• Version / Model: MRASI0016
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-23
• Public Version: 2
• Public Version Date: 2026-03-20
• Public Version Status: Update
• Public Device Record Key: ed436c25-84f9-445b-89a3-82a92ae47617

Device Description

Toothed Grasper

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: 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
63113	Robotic surgical forceps, reusable	A surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521851023	GS1

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: Storage Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius