Steri-Shield 0424-655-000

GUDID 07613327625158

8 Charger

STRYKER CORPORATION

Surgical helmet system

• Primary Device ID: 07613327625158
• NIH Device Record Key: bdb21324-596c-47c4-baad-14df37b01655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steri-Shield
• Version Model Number: 0424655000
• Catalog Number: 0424-655-000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327625158 [Primary]

FDA Product Code

• LYU: ACCESSORY, SURGICAL APPAREL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-03
• Device Publish Date: 2025-02-21

On-Brand Devices [Steri-Shield]

• 37613327625487: 8 Tie Back Toga with Peel Away Face Shield
• 37613327625470: 8 Tie Back Toga with Peel Away Face Shield
• 37613327625463: 8 Tie Back Toga with Anti-Reflective Face Shield
• 37613327625456: 8 Tie Back Toga with Anti-Reflective Face Shield
• 37613327625449: 8 Tie Back Toga with Anti-Reflective Face Shield
• 37613327625432: 8 Tie Back Toga with Peel Away Face Shield
• 37613327625425: 8 Tie Back Toga with Peel Away Face Shield
• 37613327625418: 8 Tie Back Toga with Anti-Reflective Face Shield
• 37613327625401: 8 Tie Back Toga, Standard
• 37613327625395: 8 Tie Back Toga, Standard
• 37613327625388: 8 Tie Back Toga, Standard
• 37613327625371: 8 Tie Back Toga, Standard
• 37613327625364: 8 Zippered Toga with Anti-Reflective Face Shield
• 37613327625357: 8 Zippered Toga with Anti-Reflective Face Shield
• 37613327625340: 8 Zippered Toga with Anti-Reflective Face Shield
• 37613327625333: 8 Zippered Toga with Anti-Reflective Face Shield
• 37613327625326: 8 Pullover Toga with Anti-Reflective Face Shield
• 37613327625319: 8 Zippered Toga with Peel Away Face Shield
• 37613327625302: 8 Zippered Toga with Peel Away Face Shield
• 37613327625296: 8 Zippered Toga with Peel Away Face Shield
• 37613327625289: 8 Pullover Toga with Anti-Reflective Face Shield
• 37613327625272: 8 Pullover Toga with Anti-Reflective Face Shield
• 37613327625265: 8 Zippered Toga with Peel Away Face Shield
• 37613327625258: 8 Pullover Toga with Anti-Reflective Face Shield
• 37613327625241: 8 Pullover Toga with Peel Away Face Shield
• 37613327625234: 8 Hood with Anti-Reflective Face Shield
• 37613327625227: 8 Pullover Toga with Peel Away Face Shield
• 37613327625210: 8 Pullover Toga with Peel Away Face Shield
• 37613327625197: 8 Pullover Toga with Peel Away Face Shield
• 37613327625180: 8 Hood with Peel Away Face Shield
• 37613327625173: 8 Hood, Standard
• 07613327625158: 8 Charger