Nova 10 Fiducial Marker

GUDID 00863593000273

C4 IMAGING, LLC

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 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 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 ID00863593000273
NIH Device Record Key090abe6e-11c2-43fa-bec5-9359489f6b10
Commercial Distribution Discontinuation2022-04-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNova 10 Fiducial Marker
Version Model NumberF-01-03-0115
Company DUNS003065466
Company NameC4 IMAGING, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100863593000273 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-03
Device Publish Date2022-04-25

Devices Manufactured by C4 IMAGING, LLC

00863593000273 - Nova 10 Fiducial Marker2022-05-03
00863593000273 - Nova 10 Fiducial Marker2022-05-03
00863593000242 - Nova 52021-09-13 The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobal
00863593000259 - Nova 52021-09-13 The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobal
00863593000235 - HDR MRI Lumen Marker2018-07-12 The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline
00863593000204 - Sirius MRI Marker2018-07-06 The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sle
00863593000211 - Sirius MRI Marker2018-07-06 The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sle
00863593000228 - Sirius MRI Marker NS2018-07-06 The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier
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