Workflow Box

GUDID B334WORKFLOWBOX2P60

MIRADA MEDICAL LIMITED

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• Primary Device ID: B334WORKFLOWBOX2P60
• NIH Device Record Key: 8b5f5eef-50a0-4c9c-afe0-e9b890307044
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Workflow Box
• Version Model Number: 2.6
• Company DUNS: 211100325
• Company Name: MIRADA MEDICAL LIMITED
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B334WORKFLOWBOX2P60 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181572

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-05-12
• Device Publish Date: 2021-05-04

On-Brand Devices [Workflow Box]

• B334WORKFLOWBOX2P00: 2.0
• B334WORKFLOWBOX2P20: 2.2
• B334WORKFLOWBOX2P40: 2.4
• B334WORKFLOWBOX2P60: 2.6