FDA.reportPublic FDA data

Gold Anchor

Primary DI
07340145700063
Brand
Gold Anchor
Company
Naslund Medical AB
Model
GA200-10-G
Catalog number
0006
Device description
Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x10 mm pre-loaded in (1) Fine Needle 22G 0.7x200 mm.
Published
2016-06-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091645000GOLD ANCHORNaslund Medical AB2009-07-21IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340145700070PackageGS110In Commercial Distribution
07340145700063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340145700070073401457000707340145700070
07340145700063073401457000637340145700063

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
351991547
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07340145700025Gold AnchorGA150-10-G00022016-06-08
07340145700049Gold AnchorGA150-20-G00042016-06-08
07340145700124Gold AnchorGA200-20-BG00122016-06-08
07340145700148Gold AnchorGA200X-10-G00142016-06-08
07340145700162Gold AnchorGA200X-20-G00162016-06-08
07340145700186Gold AnchorGA200X-10-BG00182016-06-08
07340145700209Gold AnchorGA200X-20-BG00202016-06-08
07340145700223Gold AnchorGA150-1000222016-09-12
07340145700308Gold AnchorGA200-10-B00302016-09-12
07340145700322Gold AnchorGA200-20-B00322016-09-12
07340145700346Gold AnchorGA200X-1000342016-09-12
07340145700360Gold AnchorGA200X-2000362016-09-12
07340145700384Gold AnchorGA200X-10-B00382016-09-12
07340145700407Gold Anchor GA200X-20-B00402016-09-12
07340145700421Gold AnchorGA150X-1000422023-01-23
07340145700445Gold AnchorGA150X-2000442023-01-23
07340145700469Gold AnchorGA150X-10-B00462017-11-20
07340145700483Gold AnchorGA150X-20-B00482017-11-20
07340145700506Gold AnchorGA250-1000502023-01-23
07340145700544Gold AnchorGA250-10-B00542018-04-12

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Primary DI, Brand, Company table
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00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
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00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22