FDA.reportPublic FDA data

Mammotome Prima

Primary DI
00841911102489
Brand
Mammotome Prima
Company
DEVICOR MEDICAL PRODUCTS, INC.
Model
MRTRAY1
Catalog number
CA001007001
Device description
Mammotome Prima Reusable Tray - CE
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K260365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260365000Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.2026-03-04KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841911102489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841911102489008419111024898419111024890841911102489

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961832156
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841911100188HydroMarkCA0004080014010-04-09-T12018-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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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
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06937278635228CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635235CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635266CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635273CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635280CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
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