Hugo RAS

GUDID 30884521851065

Upper Arm Sterile Drape

Covidien LP

Medical equipment/instrument drape, single-use

• Primary Device ID: 30884521851065
• NIH Device Record Key: 031d5376-f6fb-480a-b438-30baea396fb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hugo RAS
• Version Model Number: MRASA0007
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521851061 [Primary]
GS1	30884521851065 [Package]; Contains: 10884521851061; Package: CASE [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250725

FDA Product Code

• SCV: Modular electromechanical surgical system

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-02
• Device Publish Date: 2025-12-25

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