SmartClip Lite - Eval Kit SMARTCLIPLT-EVALKIT

GUDID 00851674008560

SmartClip Lite- Evaluation Kit

Elucent Medical, Inc.

Radiological image marker, implantable

• Primary Device ID: 00851674008560
• NIH Device Record Key: d6d505b2-db5d-4c36-bcf8-64344be8c1cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartClip Lite - Eval Kit
• Version Model Number: SMARTCLIPLT-EVALKIT
• Catalog Number: SMARTCLIPLT-EVALKIT
• Company DUNS: 079322481
• Company Name: Elucent Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851674008560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180640

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: 2026-03-05
• Device Publish Date: 2026-02-25

Devices Manufactured by Elucent Medical, Inc.

• 00851674008560 - SmartClip Lite - Eval Kit: 2026-03-05SmartClip Lite- Evaluation Kit
• 00851674008560 - SmartClip Lite - Eval Kit: 2026-03-05 SmartClip Lite- Evaluation Kit
• 00851674008577 - SmartClip: 2026-02-24 Soft Tissue Marker and Delivery System - Violet, 5 cm (T-Lock)
• 00851674008584 - SmartClip: 2026-02-24 Soft Tissue Marker and Delivery System - Violet, 7.5 cm (T-Lock)
• 00851674008591 - SmartClip: 2026-02-24 Soft Tissue Marker and Delivery System - Violet, 10 cm (T-Lock)
• 00851674008607 - SmartClip Secure: 2026-02-24 Soft Tissue Marker and Delivery System - Violet (T-Lock)
• 10851674008352 - SmartClip Secure: 2025-06-09 Soft Tissue Marker and Delivery System - Pink
• 10851674008369 - SmartClip Secure: 2025-06-09 Soft Tissue Marker and Delivery System - Green
• 10851674008376 - SmartClip Secure: 2025-06-09 Soft Tissue Marker and Delivery System - Purple