SenoMark UltraCor™ MRI Breast Tissue Marker SMUCMRI14GT

GUDID 10801741032155

SENOMARK ULTRACOR™ MRI Breast Tissue Marker, 14 Ga, Titanium "X"

SENORX, 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 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 ID10801741032155
NIH Device Record Key20c45b07-3190-4a59-b096-89f66e712477
Commercial Distribution StatusIn Commercial Distribution
Brand NameSenoMark UltraCor™ MRI Breast Tissue Marker
Version Model NumberSMUCMRI14GT
Catalog NumberSMUCMRI14GT
Company DUNS043674543
Company NameSENORX, 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com

Device Dimensions

Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge
Device Size Text, specify0
Needle Gauge14 Gauge

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741032158 [Primary]
GS110801741032155 [Package]
Contains: 00801741032158
Package: CA [5 Units]
In Commercial Distribution

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 Date2015-10-02

On-Brand Devices [SenoMark UltraCor™ MRI Breast Tissue Marker]

10801741032155SENOMARK ULTRACOR™ MRI Breast Tissue Marker, 14 Ga, Titanium "X"
10801741032148SENOMARK ULTRACOR™ MRI Breast Tissue Marker, 14 Ga, SS "M"

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