BIOMARC ® EX 040165

GUDID 10850002461302

FIDUCIAL MARKER SYSTEM

Carbon Medical Technologies, Inc.

Imaging lesion localization marker, implantable
Primary Device ID10850002461302
NIH Device Record Key9dc853d5-184c-4c70-b36e-ce86af33e139
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOMARC ® EX
Version Model Number040165
Catalog Number040165
Company DUNS883094039
Company NameCarbon Medical Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM
Phone6516538512
EmailINFO@CARBONMED.COM

Device Dimensions

Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0
Outer Diameter0.7 Millimeter
Length5 Millimeter
Needle Gauge20 Gauge
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002461305 [Primary]
GS110850002461302 [Package]
Contains: 00850002461305
Package: CARTON [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-15
Device Publish Date2022-02-07

Devices Manufactured by Carbon Medical Technologies, Inc.

10850002461340 - BiomarC®2024-07-31 FIDUCIAL MARKER SYSTEM, EX
10850002461357 - Carbon Bright ®2024-07-31 CARBON FIDUCIAL MARKER - DISTAL DELIVERY
10850002461302 - BIOMARC ® EX2022-02-15FIDUCIAL MARKER SYSTEM
10850002461302 - BIOMARC ® EX2022-02-15 FIDUCIAL MARKER SYSTEM
00850002461091 - BiomarC® Restore2021-12-24 LOW DENSITY FIDUCIAL MARKER
00850002461107 - BIOMARC® RESTORE 2021-12-24 LOW DENSITY FIDUCIAL MARKER
00850002461152 - BIOMARC ® RESTORE2021-12-24 MIDDLE DENSITY FIDUCIAL MARKER
00850002461169 - BIOMARC ® RESTORE2021-12-24 HIGH DENSITY FIDUCIAL MARKER
00850002461176 - BIOMARC ® RESTORE2021-12-24 MIDDLE DENSITY FIDUCIAL MARKER

Trademark Results [BIOMARC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOMARC
BIOMARC
78515741 not registered Dead/Abandoned
Image Process Technology, Inc
2004-11-12
BIOMARC
BIOMARC
76434065 2985769 Live/Registered
Carbon Medical Technologies, Inc.
2002-07-25

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