FDA.reportPublic FDA data

PolyMark™

Primary DI
00853730006336
Brand
PolyMark™
Company
CORTEX MANUFACTURING INC.
Model
PM-0.8-3
Device description
Implanted Marker
Published
2015-08-24
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

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102506000MIXED MEDIA MARKERCortex Manufacturing, Inc.2011-01-12NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853730006336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853730006336008537300063368537300063360853730006336

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
832596816
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
00853730006008FlexiMarc™FM-0.9-2-10-GG-18-202015-08-24
00853730006015FlexiMarc™FM-0.9-3-10-GG-18-202015-08-24
00853730006022FlexiMarc™FM-1.2-2-10-GG-17-202015-08-24
00853730006039FlexiMarc™FM-1.2-3-10-GG-17-202015-08-24
00853730006046FlexiCoil™FC-0.6-2-10-GG-20-202015-08-24
00853730006053FlexiCoil™FC-0.9-2-10-GG-18-202015-08-24
00853730006060FlexiCoil™FC-0.9-2-20-GG-18-202015-08-24
00853730006077FlexiCoil™FC-1.2-2-10-GG-17-202015-08-24
00853730006084FlexiCoil™FC-1.2-2-20-GG-17-202015-08-24
00853730006091FlexiMarc G/T™FM-1.0-2-10-GT-18-202015-08-24
00853730006107FlexiMarc G/T™FM-1.0-2-20-GT-18-202015-08-24
00853730006114FlexiMarc G/T™FM-1.2-2-10-GT-17-202015-08-24
00853730006121FlexiMarc G/T™FM-1.2-2-20-GT-17-202015-08-24
00853730006138PointCoil™PC-0.6-1-5-GG-20-202015-08-24
00853730006145PointCoil™PC-0.8-1-5-GG-NL2015-08-24
00853730006152PointCoil™PC-0.8-1-5-GG-18-52015-08-24
00853730006169PointCoil™PC-0.9-1-5-GG-18-202015-08-24
00853730006176PolyMark™PM-1.0-3-18-202015-08-24
00853730006183PolyMark™PM-1.0-5-18-202015-08-24
00853730006190PolyMark™PM-1.0-3-18-252015-08-24

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Primary DI, Brand, Company table
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