FDA.reportPublic FDA data

Mammotome

Primary DI
10841911101137
Brand
Mammotome
Company
DEVICOR MEDICAL PRODUCTS, INC.
Model
G011LF
Device description
Probe Guide
Published
2022-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943863000NEEDLE GUIDEBiopsys Medical, Inc.1994-12-29IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841911101137PackageGS125In Commercial Distribution
00841911101130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084191110113710841911101137
00841911101130008419111011308419111011300841911101130

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge11Gauge

Sterilization Methods#

Method table
Method

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
false
Expiration date on label
true
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
00841911103653HydroMARKCA0005150064010-05-08-T42026-07-07
00841911103776Mammotome PrimaMRPROBE08CA0007780012026-06-09
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
00841911101826MammotomeSCMC3DIRECT 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYN2026-07-24
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYN2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYN2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYN2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
06903053124348Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124355Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124379Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124430Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124461Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124492Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124546Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124560Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124591Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124607Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03