FDA.reportPublic FDA data

Brevera Breast Biopsy System

Primary DI
15420045515161
Brand
Brevera Breast Biopsy System
Company
Hologic, Inc.
Model
BREVDRV-02
Catalog number
BREVDRV-02
Device description
Reusable Driver
Published
2024-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K163052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163052000Brevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc.2017-03-29KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045515161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551516115420045515161

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

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

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