SuperLock

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: SuperLock FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: Fiducial Marker;Nitinol Coil FDA UDI
Model / Reference: SDGN447 FDA UDI
Description: Fiducial Marker;Nitinol Coil FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521762688 FDA UDI
FDA Product Code: JAK FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1750 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

Dimensions & Sizes

Size: Width — 4.0 Millimeter FDA UDI
Length — 7.0 Millimeter FDA UDI

Category: Radiological image marker, implantable

SuperLock by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Covidien LP

Sources (1)

FDA UDI d8968d5d-0676-4dc3-8427-a4af5a185c05 36 fields · synced May 30, 2026