SmartClip Secure SMARTCLIP-SEC-VLT

GUDID 00851674008607

Soft Tissue Marker and Delivery System - Violet (T-Lock)

Elucent Medical, Inc.

Radiological image marker, implantable
Primary Device ID00851674008607
NIH Device Record Key705d21ef-277d-4fea-8ad6-cff423186428
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartClip Secure
Version Model NumberSMARTCLIP-SEC-VLT
Catalog NumberSMARTCLIP-SEC-VLT
Company DUNS079322481
Company NameElucent Medical, Inc.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-417-1700
Emailcustomerservice@elucent.com
Phone844-417-1700
Emailcustomerservice@elucent.com
Phone844-417-1700
Emailcustomerservice@elucent.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851674008607 [Unit of Use]
GS110851674008604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEUMarker, Radiographic, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-24
Device Publish Date2026-02-16

On-Brand Devices [SmartClip Secure]

10851674008376Soft Tissue Marker and Delivery System - Purple
10851674008369Soft Tissue Marker and Delivery System - Green
10851674008352Soft Tissue Marker and Delivery System - Pink
00851674008607Soft Tissue Marker and Delivery System - Violet (T-Lock)

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