Gold Anchor

Primary DI
07340145700186
Brand
Gold Anchor
Company
Naslund Medical AB
Model
GA200X-10-BG
Catalog number
0018
Device description
Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.40x10 mm pre-loaded in (1) Fine Needle 20G 0.9x200 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
OTC
false
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
07340145700193PackageGS110Not in Commercial Distribution
07340145700186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340145700193073401457001937340145700193
07340145700186073401457001867340145700186

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 radiological 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. It is not an electromagnetic or optical spatial marker.

Regulatory Flags#

DUNS number
351991547
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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 AnchorGA200X-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
07340145700568Gold AnchorGA250-20-B00562018-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277411815Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
00850002461343BiomarC®Carbon Medical Technologies, Inc.IYE2024-07-23
00850002461350Carbon Bright ®Carbon Medical Technologies, Inc.IYE2024-07-23
00850016008176VeraFormViscus Biologics LLCIYE2024-01-16
07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700445Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700506Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700582Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700643Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700667Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701060Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701084Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701107Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701121Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701145Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701169Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701183Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701206Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701220Gold AnchorNaslund Medical ABIYE2023-01-23
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