BiomarC ® 040143

GUDID 00858015005646

Coaxial Needle

Carbon Medical Technologies, Inc.

Nonimplantable needle guide, single-use
Primary Device ID00858015005646
NIH Device Record Key2aa4331d-eb10-4e9a-b525-c4c449d487b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiomarC ®
Version Model Number040143
Catalog Number040143
Company DUNS883094039
Company NameCarbon Medical Technologies, Inc.
Device Count1
DM Exempttrue
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 Latextrue
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
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
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
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge
Length8.5 Centimeter
Needle Gauge18 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100858015005646 [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 Number5
Public Version Date2019-10-07
Device Publish Date2016-10-12

On-Brand Devices [BiomarC ® ]

00858015005646Coaxial Needle
10858015005087Fiducial Marker - EX
10858015005070Fiducial Marker, Gold
10858015005063Tissue Marker, kV

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

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