SYSTEM 1 endo P6900

GUDID 00724995170554

SYSTEM 1 endo Liquid Chemical Sterilant Processing System with Touchscreen is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive, semi-critical medical devices.

Corporation Steris Canada

Liquid sterilant sterilizer

• Primary Device ID: 00724995170554
• NIH Device Record Key: 32d17518-607e-4f35-950d-9adccacb0fde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYSTEM 1 endo
• Version Model Number: 1 endo
• Catalog Number: P6900
• Company DUNS: 202659140
• Company Name: Corporation Steris Canada
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995170554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182827

FDA Product Code

• MED: Sterilant, 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: 2019-12-18
• Device Publish Date: 2019-10-04

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