Gold Anchor

FDA UDI

Class II (US FDA UDI)

by Naslund Medical AB

Identity

Trade Name: Gold Anchor FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: Fiducial Gold Marker. (1) Gold Anchor Marker 0.28x20 mm pre-loaded in (1) Fine Needle 22G 0.7x200 mm. FDA UDI
Model / Reference: GA200-20 FDA UDI
Description: Fiducial Gold Marker. (1) Gold Anchor Marker 0.28x20 mm pre-loaded in (1) Fine Needle 22G 0.7x200 mm. FDA UDI

Identifiers

Catalog Number: 0028 FDA UDI
Primary DI / UDI-DI: 07340145700285 FDA UDI
510(k) Number: K160209 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 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

Gold Anchor by Naslund Medical AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K160209 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: Naslund Medical AB

Sources (1)

FDA UDI 0adea593-c133-4eea-8386-8b815fce7e32 35 fields · synced Jun 8, 2026