FDA.report

Gold Fiducial

Primary DI
00815212020131
Brand
Gold Fiducial
Company
Izi Medical Products, LLC
Model
GF1523
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications

CodeDeviceSpecialtyClass
KXKSource, Brachytherapy, RadionuclideRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815212020131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212020131008152120201318152120201310815212020131

GMDN Terms

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

Regulatory Flags

DUNS number
933506164
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

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