Sim&Size

GUDID 03665786000025

SIM&CURE

Radiology DICOM image processing application software

• Primary Device ID: 03665786000025
• NIH Device Record Key: 72b35393-5783-47d6-914b-256fe377911c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sim&Size
• Version Model Number: Version 1.0.5
• Company DUNS: 266338887
• Company Name: SIM&CURE
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665786000025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190049

FDA Product Code

• PZO: Software For Visualization Of Vascular Anatomy And Intravascular 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: 2020-08-07
• Device Publish Date: 2020-07-30

On-Brand Devices [Sim&Size]

• 03665786000025: Version 1.0.5
• 03665786000056: V1.0.7
• 03665786000049: V1.0.6
• 03665786000063: V1.1
• 03665786000032: V1.2