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
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
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 table
Method

Regulatory Flags#

DUNS number
832596816
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
00853730006206FusionCoil™FC-1.0-5-18-202015-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450392850SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392867SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392874SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392881SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392935SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392942SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392959SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392966SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
10851674008574SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008581SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008598SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008604SmartClip SecureElucent Medical, Inc.NEU2026-02-16
10851674008468SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008475SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008482SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008499SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008505SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008512SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008529SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008536SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008543SmartClipElucent Medical, Inc.NEU2025-10-01
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
00801741226342UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
08719992742516Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742530Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742592Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742882Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742943Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742974Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742998Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22