FDA.reportPublic FDA data

SenoMark® Breast Tissue Marker

Primary DI
10801741031967
Brand
SenoMark® Breast Tissue Marker
Company
SENORX, INC.
Model
SMSE9GT
Catalog number
SMSE9GT
Device description
SENOMARK® Breast Tissue Marker, 9 Ga Eviva, Titanium "X"
Published
2015-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEUMARKER, RADIOGRAPHIC, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050090000GEL MARK VSenorx, Inc.2005-02-07NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741031967PackageGS110In Commercial Distribution
00801741031960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103196710801741031967
00801741031960008017410319608017410319600801741031960

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge9Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature025 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
043674543
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741086496EnCorENCFNGUIDE01ENCFNGUIDE012024-04-15
00801741031847Gel Mark Ultra™ Breast Tissue MarkerGMU11TGMU11T2015-10-01
00801741031885Gel Mark Ultra™ Breast Tissue MarkerMK2011MK20112015-10-01
00801741032165StarchMark® Breast Tissue MarkerSTMKEC10GSSSTMKEC10GSS2015-10-02
00801741032172StarchMark® Breast Tissue MarkerSTMKEC7GSSSTMKEC7GSS2015-10-02
00801741032189StarchMark® Breast Tissue MarkerSTMKMT11GSSSTMKMT11GSS2015-10-02
00801741032196StarchMark® UltraCor™ Breast Tissue MarkerSTMK14GSSSTMK14GSS2015-10-02
00801741086182ENCOR®ECCOAXCAN10GECCOAXCAN10G2016-09-20
00801741086199ENCOR®ECCOAXCAN12GECCOAXCAN12G2016-09-20
00801741086373EnCor®ECSTUS0112GECSTUS0112G2016-09-20
00801741086380EnCor®ECSTUS0110GECSTUS0110G2016-09-20
00801741086397EnCor®ECSTUS017GECSTUS017G2016-09-20
00801741086052ENCOR®CM3000CM30002016-09-20
00801741086441ENCOR®ENCFF01ENCFF012016-09-20
00801741086755ENCOR®VS3000VS30002016-09-20
00801741031854Gel Mark Ultra™ Breast Tissue MarkerGMUEC10GSSGMUEC10GSS2015-10-01
00801741031861Gel Mark Ultra™ Breast Tissue MarkerGMUEC7GSSGMUEC7GSS2015-10-01
00801741031892Gel Mark UltraCor® Breast Tissue MarkerGMUTC005SSGMUTC005SS2015-10-01
00801741031908Gel Mark UltraCor® Breast Tissue MarkerGMUTC005TGMUTC005T2015-10-01
00801741031915SenoMark® Breast Tissue MarkerSMEC10GSSSMEC10GSS2015-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450392850SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392867SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392874SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392881SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392935SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392942SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392959SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392966SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
10851674008574SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008581SmartClipElucent Medical, Inc.NEU2026-02-16
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10851674008604SmartClip SecureElucent Medical, Inc.NEU2026-02-16
10851674008468SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008475SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008482SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008499SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008505SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008512SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008529SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008536SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008543SmartClipElucent Medical, Inc.NEU2025-10-01
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
00801741226342UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
08719992742516Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742530Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742592Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742882Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742943Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742974Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742998Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22