SmartClip

FDA UDI

Class II (US FDA UDI)

by Elucent Medical Inc.

Identity

Trade Name: SmartClip FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: Soft tissue marker and delivery system - Green, 5cm FDA UDI
Model / Reference: SMARTCLIP LITE, GREEN, 5CM FDA UDI
Description: Soft tissue marker and delivery system - Green, 5cm FDA UDI

Identifiers

Catalog Number: SMARTCLIPLT-GRN-5 FDA UDI
Primary DI / UDI-DI: 10851674008277 FDA UDI
510(k) Number: K180640 FDA UDI
FDA Product Code: NEU FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Radiological image marker, implantable

SmartClip by Elucent Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Radiological image marker, implantable.

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HydroMark — Devicor Medical Products, Inc. · Class II
AutoMark — M.D.L. S.R.L. · Class I
X-Mark Ultra — IZI MEDICAL PRODUCTS LLC · Class II

Cleared under the same submission

K180640 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Elucent Medical Inc.

Sources (1)

FDA UDI fbbb61fe-1243-4f11-b43e-03b1b93243c0 37 fields · synced May 30, 2026