EnVisio System

GUDID 00851674008553

EnVisio System including the following components: SmartSurface, foot pedal and heads-up display

Elucent Medical, Inc.

Radiological image marker, implantable

• Primary Device ID: 00851674008553
• NIH Device Record Key: c12f0e25-b93c-43be-8bdf-8b2e20cc4fa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnVisio System
• Version Model Number: ENVISIO-SYS
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com
• Phone: 844-417-1700
• Email: Customerservice@elucent.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851674008553 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-12
• Device Publish Date: 2025-02-04

Devices Manufactured by Elucent Medical, Inc.

• 00851674008553 - EnVisio System: 2025-02-12EnVisio System including the following components: SmartSurface, foot pedal and heads-up display
• 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
• 00851674008287 - SmartClip: 2022-11-14 Soft tissue marker and delivery system - Green, 7.5cm