Modus Plan SYN-0866

GUDID 00670082000443

Synaptive Medical Inc

Radiology PACS software

• Primary Device ID: 00670082000443
• NIH Device Record Key: f2f3a51c-cba6-4fe5-99ca-27aadbc4e053
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modus Plan
• Version Model Number: 2.0
• Catalog Number: SYN-0866
• Company DUNS: 203061833
• Company Name: Synaptive Medical Inc
• 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: false
• 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
GS1	00670082000443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180394

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: 2019-08-14
• Device Publish Date: 2019-08-06

On-Brand Devices [Modus Plan]

• 00670082000443: 2.0
• 00670082000511: 2.1