FDA.reportPublic FDA data

Mammotome Revolve EX Holster

Primary DI
00841911102861
Brand
Mammotome Revolve EX Holster
Company
DEVICOR MEDICAL PRODUCTS, INC.
Model
MHEXH1
Catalog number
CA000609001
Device description
Holster for ultrasound guided procedures
Published
2025-09-18
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
K202012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202012000Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemDevicor Medical Products, Inc.2020-08-18KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841911102861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841911102861008419111028618419111028610841911102861

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
961832156
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841911103776Mammotome PrimaMRPROBE08CA0007780012026-06-09
00841911103653HydroMARKCA0005150064010-05-08-T42026-07-07
00841911100003HydroMarkCA0004100044010-01-08-S12018-10-10
00841911100010HydroMarkCA0004100014010-01-08-T12018-10-10
00841911100027HydroMarkCA0004100024010-01-08-T32018-10-10
00841911100034HydroMarkCA0004100034010-01-08-T42018-10-10
00841911100041HydroMarkCA0004110014010-01-11-T12018-10-10
00841911100058HydroMarkCA0004110024010-01-11-T32018-10-10
00841911100065HydroMarkCA0004110034010-01-11-T42018-10-10
00841911100072HydroMarkCA0004070014010-02-15-S12016-12-13
00841911100089HydroMarkCA0004070024010-02-15-S32016-12-13
00841911100096HydroMarkCA0004070034010-02-15-T12016-12-13
00841911100102HydroMarkCA0004070044010-02-15-T32016-12-13
00841911100119HydroMarkCA0004070054010-02-15-T42016-12-13
00841911100126HydroMarkCA0004090014010-02-18-T32016-12-13
00841911100133HydroMarkCA0004130014010-03-09-T12016-12-13
00841911100140HydroMarkCA0004130024010-03-09-T32016-12-13
00841911100157HydroMarkCA0004120014010-03-15-T1-SHORT2016-12-13
00841911100164HydroMarkCA0004120024010-03-15-T3-SHORT2016-12-13
00841911100171HydroMarkCA0004080044010-04-09-S32018-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543911Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543928Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543935Arthrex®ARTHREX, INC.KNW2026-09-25
08681672056520MaxiCore-M Reusable Automatic Biopsy GunGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIKNW2026-09-22
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
06937278634917CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634924CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634962CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635013CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635020CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635037CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635068CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635075CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635082CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635112CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635129CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635136CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635167CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635174CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635181CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635211CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635228CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635235CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15