FDA.reportPublic FDA data

ENCOR®

Primary DI
00801741086236
Brand
ENCOR®
Company
SENORX, INC.
Model
ECMRINTLOC7G
Catalog number
ECMRINTLOC7G
Device description
ENCOR® Breast Biopsy System MRI Introducer Set Visiloc™ 7G
Published
2016-09-20
Public version status
Update
Distribution status
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
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161805000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161805000EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc.2016-07-19KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741086236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741086236008017410862368017410862360801741086236

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, non-medicatedA collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.

Device Sizes#

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

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
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
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
06937278628312CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628329CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628336CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628343CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628350CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628367CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628374CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31