FDA.reportPublic FDA data

Gel Mark UltraCor® Breast Tissue Marker

Primary DI
00801741031892
Brand
Gel Mark UltraCor® Breast Tissue Marker
Company
SENORX, INC.
Model
GMUTC005SS
Catalog number
GMUTC005SS
Device description
GEL MARK ULTRACOR Breast Tissue Marker, 14 Gauge, SS "Omega"
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
K040706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040706000GEL MARK IVSenorx, Inc.2004-04-08NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741031899PackageGS110In Commercial Distribution
00801741031892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103189910801741031899
00801741031892008017410318928017410318920801741031892

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 radiological 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. It is not an electromagnetic or optical spatial marker.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Needle Gauge0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

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
00801741031847Gel Mark Ultra™ Breast Tissue MarkerGMU11TGMU11T2015-10-01
00801741031854Gel Mark Ultra™ Breast Tissue MarkerGMUEC10GSSGMUEC10GSS2015-10-01
00801741031861Gel Mark Ultra™ Breast Tissue MarkerGMUEC7GSSGMUEC7GSS2015-10-01
00801741031885Gel Mark Ultra™ Breast Tissue MarkerMK2011MK20112015-10-01
00801741031908Gel Mark UltraCor® Breast Tissue MarkerGMUTC005TGMUTC005T2015-10-01
00801741031915SenoMark® Breast Tissue MarkerSMEC10GSSSMEC10GSS2015-10-01
00801741031922SenoMark® Breast Tissue MarkerSMEC12GSSSMEC12GSS2015-10-01
00801741031939SenoMark® Breast Tissue MarkerSMEC7GSSSMEC7GSS2015-10-01
00801741031946SenoMark® Breast Tissue MarkerSMRSU12GTSMRSU12GT2015-10-01
00801741031953SenoMark® Breast Tissue MarkerSMRSU9GTSMRSU9GT2015-10-01
00801741031960SenoMark® Breast Tissue MarkerSMSE9GTSMSE9GT2015-10-01
00801741031977SenoMark® Breast Tissue MarkerSMTEC10GSMTEC10G2015-10-01
00801741031984SenoMark® Breast Tissue MarkerSMTMT11GSMTMT11G2015-10-01
00801741031991SenoMark® Breast Tissue MarkerSMTSU9GSMTSU9G2015-10-01
00801741032141SenoMark UltraCor™ MRI Breast Tissue MarkerSMUCMRI14GSSSMUCMRI14GSS2015-10-02
00801741032158SenoMark UltraCor™ MRI Breast Tissue MarkerSMUCMRI14GTSMUCMRI14GT2015-10-02
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

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