Carbon Bright® 040152

GUDID 10850002461050

Fiducial Marker System

Carbon Medical Technologies, Inc.

Imaging lesion localization marker, implantable
Primary Device ID10850002461050
NIH Device Record Keye9fed457-46a1-4597-b63d-baf5d06561d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarbon Bright®
Version Model Number040152
Catalog Number040152
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

Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com

Device Dimensions

Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length5 Millimeter
Outer Diameter1 Millimeter
Length20 Centimeter
Needle Gauge18 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002461053 [Primary]
GS110850002461050 [Package]
Contains: 00850002461053
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 Date2020-01-16
Device Publish Date2020-01-08

On-Brand Devices [Carbon Bright®]

10850002461050Fiducial Marker System
10850002461043Fiducial Marker

Trademark Results [Carbon Bright]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARBON BRIGHT
CARBON BRIGHT
87814203 5579779 Live/Registered
Fields, Perry L.
2018-02-28

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