StarchMark® Breast Tissue Marker STMKMT11GSS

GUDID 10801741032186

STARCHMARK® Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"

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 ID10801741032186
NIH Device Record Keya2758072-cda4-44b1-ad53-5b077b4a6b2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameStarchMark® Breast Tissue Marker
Version Model NumberSTMKMT11GSS
Catalog NumberSTMKMT11GSS
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
GS100801741032189 [Primary]
GS110801741032186 [Package]
Contains: 00801741032189
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 Date2015-10-02

On-Brand Devices [StarchMark® Breast Tissue Marker]

10801741032186STARCHMARK® Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"
10801741032179STARCHMARK® Breast Tissue Marker, 7 Ga EnCor, SS “V”
10801741032162STARCHMARK® Breast Tissue Marker, 10 Ga EnCor, SS "Omega"

Trademark Results [StarchMark]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STARCHMARK
STARCHMARK
77748052 3731151 Live/Registered
C. R. BARD, INC.
2009-05-29

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