FDA.reportPublic FDA data

Gold Anchor

Primary DI
07340145700544
Brand
Gold Anchor
Company
Naslund Medical AB
Model
GA250-10-B
Catalog number
0054
Device description
Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x10 mm pre-loaded in (1) Fine Needle 22G 0.7x250 mm.
Published
2018-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K160209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160209000Gold AnchorNaslund Medical AB2016-06-21IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340145700551PackageGS110In Commercial Distribution
07340145700544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340145700551073401457005517340145700551
07340145700544073401457005447340145700544

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA 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 in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, 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.

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
07340145700568Gold AnchorGA250-20-B00562018-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
08720168163325DSPS-Prominent® Cradle-VIIMACROMEDICS B.V.IYE2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.IYE2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.IYE2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.IYE2026-04-22
08720168160140DSPS-Prominent® baseplate MACROMEDICS B.V.IYE2026-04-21
08720168162557DSPS-Prominent® Cradle-IMACROMEDICS B.V.IYE2026-04-21
08720168162908Handgrips HNS, set/2MACROMEDICS B.V.IYE2026-04-21
EPTWS070031Q5200VERIQAPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-17
EPTWS0700300PQASoftPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTM600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTM600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
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