FDA.reportPublic FDA data

Mammotome MammoTest

Primary DI
00841911101208
Brand
Mammotome MammoTest
Company
DEVICOR MEDICAL PRODUCTS, INC.
Model
G1621
Catalog number
G1621
Device description
Fischer Probe Guide Holder
Published
2018-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00841911101758Direct MarkingGS10
00841911101208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841911101758008419111017588419111017580841911101758
00841911101208008419111012088419111012080841911101208

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, reusableA non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.

Contacts#

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

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

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Primary DI, Brand, Company table
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08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYN2026-08-07
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
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00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
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