SmartClip Secure SMARTCLIP-SEC-PNK

GUDID 10851674008352

Soft Tissue Marker and Delivery System - Pink

Elucent Medical, Inc.

Radiological image marker, implantable

• Primary Device ID: 10851674008352
• NIH Device Record Key: 08e4e95e-9302-4e4c-847b-0cae98b586a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartClip Secure
• Version Model Number: SMARTCLIP-SEC-PNK
• Catalog Number: SMARTCLIP-SEC-PNK
• Company DUNS: 079322481
• Company Name: Elucent Medical, Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

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
• 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
• 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	00851674008355 [Unit of Use]
GS1	10851674008352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233639

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: 2025-06-09
• Device Publish Date: 2025-06-01

On-Brand Devices [SmartClip Secure]

• 10851674008376: Soft Tissue Marker and Delivery System - Purple
• 10851674008369: Soft Tissue Marker and Delivery System - Green
• 10851674008352: Soft Tissue Marker and Delivery System - Pink