Tergazyme 1350

GUDID 00660483135011

Cleaner for ultrasonic cleaning of medical devices

ALCONOX INC

Medical device cleaning agent

• Primary Device ID: 00660483135011
• NIH Device Record Key: 3b2748be-722a-4b7c-8617-211818611f5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tergazyme
• Version Model Number: 50lb
• Catalog Number: 1350
• Company DUNS: 001478726
• Company Name: ALCONOX INC
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00660483135011 [Primary]

FDA Product Code

• FLG: Cleaner, Ultrasonic, Medical Instrument

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: 2020-10-12
• Device Publish Date: 2020-10-02

On-Brand Devices [Tergazyme]

• 00660483135011: Cleaner for ultrasonic cleaning of medical devices
• 00660483132515: Cleaner for ultrasonic cleaning of medical devices
• 00660483130597: Cleaner for ultrasonic cleaning of medical devices
• 00660483130511: Cleaner for ultrasonic cleaning of medical devices
• 00660483130498: Cleaner for ultrasonic cleaning of medical devices
• 00660483130412: Cleaner for ultrasonic cleaning of medical devices
• 00660483130313: Cleaner for ultrasonic cleaning of medical devices
• 00660483130115: Cleaner for ultrasonic cleaning of medical devices