SmartSensor

GUDID 00851674008454

EnVisio System SmartSensor & SmartCal Calibration Disk

Elucent Medical, Inc.

Radiological image marker, implantable

• Primary Device ID: 00851674008454
• NIH Device Record Key: 27e1ce3f-c612-44ef-9297-7a5df7120fbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartSensor
• Version Model Number: SMARTSENSOR
• Company DUNS: 079322481
• Company Name: Elucent Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	00851674008454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183400

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by Elucent Medical, Inc.

• 00851674008454 - SmartSensor: 2025-04-08EnVisio System SmartSensor & SmartCal Calibration Disk
• 00851674008454 - SmartSensor: 2025-04-08 EnVisio System SmartSensor & SmartCal Calibration Disk
• 00851674008553 - EnVisio System: 2025-02-12 EnVisio System including the following components: SmartSurface, foot pedal and heads-up display
• 00851674008232 - EnVisio: 2023-04-03 Envisio Navigation Patient Pad - RF Sponge Detection Compatible
• 00851674008348 - EnVisio: 2023-03-21 Screenless version of the Envisio Navigator and SmartCal Calibration Disk
• 00851674008096 - SmartClip: 2022-11-14 Soft tissue marker and delivery system - Pink, 5cm
• 00851674008256 - SmartClip: 2022-11-14 Soft tissue marker and delivery system - Pink, 7.5cm
• 00851674008263 - SmartClip: 2022-11-14 Soft tissue marker and delivery system - Pink, 10cm
• 00851674008270 - SmartClip: 2022-11-14 Soft tissue marker and delivery system - Green, 5cm