GYRUS ACMI, INC

GUDID 00821925007819

REX 6.9Fr URETEROSCOPE, 43cm

Gyrus Acmi, Inc.

Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: 00821925007819
• NIH Device Record Key: ec0a703e-30d8-4653-8ab4-8d052009ad82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GYRUS ACMI, INC
• Version Model Number: REXM3-70A
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925007819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• FAS: Electrode, Electrosurgical, Active, Urological

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: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [GYRUS ACMI, INC]

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• 00821925016101: SHAH DISC SMALL 8.5 MM DIAMETER SILICONE
• 00821925007819: REX 6.9Fr URETEROSCOPE, 43cm
• 00821925003446: AMPLATZ Guidewire 0.038" (0.97mm) x 150cm Sper Stiff Body, 9cm Straight Tip
• 00821925002579: SEMI-RIGID GYNECOLOGIC SCISSORS, 32 CM