Hugo RAS

GUDID 10884521850972

Large Needle Driver

Covidien LP

Robotic surgical needle holder, reusable

• Primary Device ID: 10884521850972
• NIH Device Record Key: b053549d-b924-419a-b862-83d67b0f7524
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hugo RAS
• Version Model Number: MRASI0006
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521850972 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250725

FDA Product Code

• SCV: Modular electromechanical surgical system

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10884521850972]

Moist Heat or Steam Sterilization

[10884521850972]

Moist Heat or Steam Sterilization

[10884521850972]

Moist Heat or Steam Sterilization

[10884521850972]

Moist Heat or Steam Sterilization

[10884521850972]

Moist Heat or Steam Sterilization

[10884521850972]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-12
• Device Publish Date: 2026-01-02

On-Brand Devices [Hugo RAS]

• 10884521827684: 3D Glasses, Observer
• 10884521851023: Toothed Grasper
• 10884521851009: Cadiere Forceps
• 30884521851072: Lower Arm Sterile Drape
• 30884521851065: Upper Arm Sterile Drape
• 30884521851058: Robotic Sterile Arm Drape
• 10884521850996: Secure Cadiere Forceps
• 10884521844629: Secure Cadiere Forceps
• 10884521826748: Secure Cadiere Forceps
• 10884521740037: Secure Cadiere Forceps
• 10884521850972: Large Needle Driver
• 10884521850965: Bipolar Maryland Forceps
• 10884521850958: Bipolar Fenestrated Grasper
• 10884521850941: Monopolar Curved Shears
• 10884521844575: Monopolar Curved Shears
• 10884521826694: Monopolar Curved Shears
• 10884521739949: Monopolar Curved Shears