FDA.reportPublic FDA data

ENCOR®

Primary DI
00801741086731
Brand
ENCOR®
Company
SENORX, INC.
Model
SCVACPAK3000
Catalog number
SCVACPAK3000
Device description
ENCOR® Breast Biopsy System Vacuum Package
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741086731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741086731008017410867318017410867310801741086731

GMDN Terms#

Term, Definition table
TermDefinition
Mammographic stereotactic biopsy systemAn assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.

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
Kit
true
Lot or batch
true
Expiration date on label
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
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
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
06936666568636CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568643CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568650CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568667CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568674CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568681CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568698CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568704CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568711CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568728CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568735CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568742CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568759CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568766CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568773CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568780CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568797CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568803CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568810CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568827CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628268CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628299CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628305CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31