CORE, Maestro 5400-201-000

GUDID 04546540503947

Drill with Handswitch

STRYKER CORPORATION

Multi-purpose surgical power tool system, pneumatic

• Primary Device ID: 04546540503947
• NIH Device Record Key: 88bfa45f-8946-4240-a011-b384f857647c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE, Maestro
• Version Model Number: 5400201000
• Catalog Number: 5400-201-000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• 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: 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
• 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
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540503947 [Primary]

FDA Product Code

• HBB: MOTOR, DRILL, PNEUMATIC

Sterilization

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

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

[04546540503947]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-05
• Device Publish Date: 2016-09-23

On-Brand Devices [CORE, Maestro]

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• 07613154410224: Universal Footpedal
• 07613154284467: Non-exhausting Footpedal
• 04546540503947: Drill with Handswitch
• 04546540469144: Footpedal
• 04546540469113: Drill
• 34546540469107: Diffuser
• 34546540469091: Oil Cartridge