SenoMark® Breast Tissue Marker SMTMT11G

GUDID 10801741031981

SENOMARK® Breast Tissue Marker, 11 Ga Mammotome, Titanium "O"

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 ID10801741031981
NIH Device Record Keyd3c9787b-4b1f-46fb-a6f6-87acc4a35751
Commercial Distribution StatusIn Commercial Distribution
Brand NameSenoMark® Breast Tissue Marker
Version Model NumberSMTMT11G
Catalog NumberSMTMT11G
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 Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 Gauge
Needle Gauge11 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
GS100801741031984 [Primary]
GS110801741031981 [Package]
Contains: 00801741031984
Package: CA [10 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 Date2015-10-01

On-Brand Devices [SenoMark® Breast Tissue Marker]

10801741031998SENOMARK® Breast Tissue Marker, 9 Ga ATEC, Titanium "O"
10801741031981SENOMARK® Breast Tissue Marker, 11 Ga Mammotome, Titanium "O"
10801741031974SENOMARK® Breast Tissue Marker, 10 Ga EnCor, Titanium "O"
10801741031967SENOMARK® Breast Tissue Marker, 9 Ga Eviva, Titanium "X"
10801741031950SENOMARK® Breast Tissue Marker, Rigid, 9 Ga ATEC, Titanium "X"
10801741031943SENOMARK® Breast Tissue Marker, Rigid, 12 Ga ATEC, Titanium "S"
10801741031936SENOMARK® Breast Tissue Marker, 7 Ga EnCor, SS "M"
10801741031929SENOMARK® Breast Tissue Marker, 12 Ga EnCor, SS "Omega"
10801741031912SENOMARK® Breast Tissue Marker, 10 Ga EnCor, SS "M"

Trademark Results [SenoMark]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SENOMARK
SENOMARK
79013114 3090510 Dead/Cancelled
B.R.A.H.M.S. Aktiengesellschaft
2005-05-27
SENOMARK
SENOMARK
77226091 3394578 Live/Registered
C. R. BARD, INC.
2007-07-10

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