Optim 1 (EU)

GUDID 07640185070738

Virox Technologies Inc

Medical device disinfection agent

• Primary Device ID: 07640185070738
• NIH Device Record Key: d216c4ec-2a89-4d00-b810-e641b8ed1571
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optim 1 (EU)
• Version Model Number: 3.78L
• Company DUNS: 255343022
• Company Name: Virox Technologies 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: true
• Lot Batch: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640185070738 [Primary]
GS1	17640185070735 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• LRJ: Disinfectant, Medical Devices

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: 2022-06-03
• Device Publish Date: 2022-05-26

Devices Manufactured by Virox Technologies Inc

• 10068460506170 - Optim 33 Tb Wipes (CAN): 2022-11-01
• 00068460506494 - Optim 1 (US): 2022-07-22
• 00068460506555 - Optim 1 (US): 2022-07-22
• 10068460506538 - Optim 1 Wipes (US): 2022-07-22
• 00068460506166 - Optim 1 (CAN): 2022-06-03
• 00068460506197 - Optim 33 Tb (CAN): 2022-06-03
• 00068460506227 - Optim 33 Tb (CAN): 2022-06-03
• 00068460506258 - Optim 33 Tb (CAN): 2022-06-03