Citrizyme Ultra Concentrated Enzyme Powder 50 Pouches 15260

GUDID 00310866000022

Ultra Concentrated Enzymatic Evacuation Cleaner and Instrument Pre-Soak 50 Packets

PASCAL COMPANY, INC.

Medical device cleaning agent

• Primary Device ID: 00310866000022
• NIH Device Record Key: 0f5b9ced-e3a9-451e-b4d9-4134789f5ad7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Citrizyme Ultra Concentrated Enzyme Powder 50 Pouches
• Version Model Number: 15260
• Catalog Number: 15260
• Company DUNS: 009260217
• Company Name: PASCAL COMPANY, INC.
• Device Count: 50
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004268051
• Email: pascal@pascaldental.com

Device Dimensions

• Weight: 4.2 Gram

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00310866000022 [Primary]
GS1	00310866001913 [Unit of Use]

FDA Product Code

• MDZ: Cleaners, Medical Devices

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2019-01-24

Devices Manufactured by PASCAL COMPANY, INC.

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• 00310866002620 - KOIS KR-4 PACKER: 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2MM HEAD
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