PolyMark™

GUDID 00853730006336

Implanted Marker

CORTEX MANUFACTURING INC.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable
Primary Device ID00853730006336
NIH Device Record Key78996d89-a19f-48de-a178-05b0613247e9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyMark™
Version Model NumberPM-0.8-3
Company DUNS832596816
Company NameCORTEX MANUFACTURING INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853730006336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEUMarker, Radiographic, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-24

On-Brand Devices [PolyMark™]

00853730006336Implanted Marker
00853730006190Implanted Marker in Needle
00853730006183Implanted Marker in Needle
00853730006176Implanted Marker in Needle

Trademark Results [PolyMark]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POLYMARK
POLYMARK
97539758 not registered Live/Pending
Cortex Manufacturing, LLC
2022-08-08
POLYMARK
POLYMARK
75204019 2138517 Live/Registered
Polymark International PLC
1996-11-18
POLYMARK
POLYMARK
74092212 1816558 Dead/Cancelled
Polymerics, Inc.
1990-08-29
POLYMARK
POLYMARK
73618955 1479635 Dead/Cancelled
POLYMARK, INC.
1986-09-09
POLYMARK
POLYMARK
73584256 1428122 Dead/Cancelled
POLYMARK, U.K., LTD.
1986-02-24
POLYMARK
POLYMARK
73534258 1395637 Live/Registered
POLYMARK INTERNATIONAL PLC
1985-04-18
POLYMARK
POLYMARK
71696820 0625283 Dead/Expired
POLYMARK LIMITED
1955-10-20
POLYMARK
POLYMARK
71640062 0637892 Dead/Expired
POLYMARK LIMITED
1952-11-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.