FDA.reportPublic FDA data

Mammotome

Primary DI
00841911101826
Brand
Mammotome
Company
DEVICOR MEDICAL PRODUCTS, INC.
Model
SCMC3
Catalog number
DIRECT MARK GTIN
Device description
Cart Upgrade- DIRECT MARK GTIN
Published
2022-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K042753000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042753000MAMMOTOME MR BIOPSY SYSTEMEthicon Endo-Surgery, Inc.2004-11-08KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841911101826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841911101826008419111018268419111018260841911101826

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
877-926-2666customersupport@mammotome.com

Regulatory Flags#

DUNS number
961832156
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841911102434Mammotome HydroMARK4010-05-10-T3CA0005200022022-03-02
00841911103677Hydromark4010-05-10-T3CA0005200052024-08-29
00841911101239MammotomeVAS08VAS082022-02-04
00841911101246MammotomeVAS11VAS112022-02-04
00841911103158Mammotome Revolve EXMCART1CA0008990012025-09-16
00841911101819MammotomeSCMC1DIRECT MARK GTIN2022-02-09
00841911101765MammotomeMFSW1DIRECT MARK2022-02-08
00841911101864Mammotome revolveMFOOT1DIRECT MARK2022-02-08
00841911101871Mammotome revolveMHKEYP1DIRECT MARK2022-02-08
00841911101888MammotomeMRLB1DIRECT MARK GTIN2022-02-08
00841911100539Mammotome MammoTestB1021B10212016-11-10
00841911100553MammotomeMFSW1MFSW12016-11-10
00841911100560MammotomeMKEY1MKEY12016-12-13
00841911100584MammotomeMRLB1MRLB12016-12-13
00841911100614MammotomeSCMC1SCMC12016-11-10
00841911100621MammotomeSCMC3SCMC32016-11-10
00841911100652Mammotome revolveMCART1MCART12016-11-10
00841911100669Mammotome revolveMFOOT1MFOOT12016-11-10
00841911100676Mammotome revolveMHKEYP1MHKEYP12016-12-13
00841911102922Hydromark Plus4010-02-15-T6CA0009150022024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636027CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636034CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636041CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636058CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636065CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636072CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636089CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636096CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636102CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636119CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636126CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636133CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636140CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636157CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636164CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636171CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636188CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636195CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636201CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636218CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636225CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636232CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636249CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636256CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31