FDA.reportPublic FDA data

Gold Anchor

Primary DI
07340145701091
Brand
Gold Anchor
Company
Naslund Medical AB
Model
GATD-10
Catalog number
0108
Device description
Gold Anchor Introducer with 0.28x10 mm marker
Published
2023-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K213053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213053000Gold AnchorNaslund Medical AB2022-01-06IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340145701091PackageGS110In Commercial Distribution
07340145701084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340145701091073401457010917340145701091
07340145701084073401457010847340145701084

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.

Sterilization Methods#

Method table
Method

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
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 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

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