FDA.reportPublic FDA data

StarchMark® UltraCor™ Breast Tissue Marker

Primary DI
00801741032196
Brand
StarchMark® UltraCor™ Breast Tissue Marker
Company
SENORX, INC.
Model
STMK14GSS
Catalog number
STMK14GSS
Device description
STARCHMARK® ULTRACOR™ Breast Tissue Marker, 14 Ga, SS “V”
Published
2015-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K131654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131654000STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERSenorx, Inc.2013-06-27NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741032193PackageGS15Not in Commercial Distribution
00801741032196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103219310801741032193
00801741032196008017410321968017410321960801741032196

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA 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 in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, 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
Device Size Text, specify0
Needle Gauge14Gauge

Contacts#

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

Regulatory Flags#

DUNS number
043674543
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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
00801741031922SenoMark® Breast Tissue MarkerSMEC12GSSSMEC12GSS2015-10-01

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
10851674008598SmartClipElucent Medical, Inc.NEU2026-02-16
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