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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Brevera Breast Biopsy System - 15420045507760

The reusable device driver is the electromechanical component of the Brevera(R) (R) Breast Biopsy system.
Hologic, Inc.
BREVDRV
In Commercial Distribution

  • 15420045507760 ()
  • 25420045507767 ()
BREVDRV

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507753

Vacuum-assisted biopsy device used to remove breast tissue in a minimally invasive manner using stereotactic or tomosyntheses imaging.
Hologic, Inc.
BREV200
In Commercial Distribution

  • 15420045507753 ()
BREV200

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507517

Vacuum-assisted biopsy device used to remove breast tissue in a minimally invasive manner using stereotactic or tomosyntheses imaging.
Hologic, Inc.
BREV100
In Commercial Distribution

  • 15420045507517 ()
  • 25420045507514 ()
BREV100

  • Mammographic stereotactic biopsy system

Affirm Breast Biopsy Guidance System - 15420045507197

Selenia Dimensions Axillary Biopsy Paddle
Hologic, Inc.
ASY-03669
In Commercial Distribution

  • 15420045507197 ()
  • 25420045507194 ()
ASY-03669

  • Mammographic stereotactic biopsy system

Affirm Breast Biopsy Guidance System - 15420045507180

Selenia Dimensions Axillary Biopsy Paddle
Hologic, Inc.
ASY-03668
In Commercial Distribution

  • 15420045507180 ()
  • 25420045507187 ()
ASY-03668

  • Mammographic stereotactic biopsy system

Affirm Breast Biopsy Guidance System - 15420045507173

Selenia Dimensions Axillary Biopsy Paddle
Hologic, Inc.
ASY-03667
In Commercial Distribution

  • 15420045507173 ()
  • 25420045507170 ()
ASY-03667

  • Mammographic stereotactic biopsy system

ATEC PEARL - 15420045506855

BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC OR ULTRASOUND GUIDANCE
Hologic, Inc.
ATEC PEARL
In Commercial Distribution

  • 15420045506855 ()
ATEC PEARL

  • Mammographic stereotactic biopsy system

ATEC EMERALD - 15420045506848

BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER MRI
Hologic, Inc.
ATEC EMERALD
In Commercial Distribution

  • 15420045506848 ()
ATEC EMERALD

  • Mammographic stereotactic biopsy system

Affirm Lateral Arm Upright Biopsy Accessory - 15420045506831

Selenia Dimensions Axillary Biopsy Paddle
Hologic, Inc.
ASY-05205
In Commercial Distribution

  • 15420045506831 ()
  • 25420045506838 ()
ASY-05205

  • Mammographic stereotactic biopsy system

Affirm Lateral Arm Upright Biopsy Accessory - 15420045506824

Affirm Lateral Arm Upright Biopsy Accessory Lateral Arm Stand
Hologic, Inc.
ASY-09644
In Commercial Distribution

  • 15420045506824 ()
  • 25420045506821 ()
ASY-09644

  • Mammographic stereotactic biopsy system

Affirm Lateral Arm Upright Biopsy Accessory - 15420045506817

Affirm Lateral Arm Upright Biopsy Accessory
Hologic, Inc.
ASY-03723
In Commercial Distribution

  • 15420045506817 ()
  • 25420045506814 ()
ASY-03723

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506541

Affirm Prone Biopsy Complete Gantry
Hologic, Inc.
ASY-09175
In Commercial Distribution

  • 15420045506541 ()
ASY-09175

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506534

AFFIRM PRONE BIOPSY ACQUISITION WORKSTATION
Hologic, Inc.
ASY-08832
In Commercial Distribution

  • 15420045506534 ()
ASY-08832

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506527

HV GENERATOR
Hologic, Inc.
ASY-06886
In Commercial Distribution

  • 15420045506527 ()
ASY-06886

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506510

AFFIRM PRONE BIOPSY SYSTEM, 3D
Hologic, Inc.
PBX-SYS-AFFIRM-3D
In Commercial Distribution

  • 15420045506510 ()
PBX-SYS-AFFIRM-3D

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506503

AFFIRM PRONE BIOPSY SYSTEM, 2D
Hologic, Inc.
PBX-SYS-AFFIRM-2D
In Commercial Distribution

  • 15420045506503 ()
PBX-SYS-AFFIRM-2D

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506497

PADDLE, BIOPSY, LATERAL, 15 CM
Hologic, Inc.
ASY-08178
In Commercial Distribution

  • 15420045506497 ()
  • 25420045506494 ()
ASY-08178

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506480

PADDLE, BIOPSY, STANDARD, 6 CM X 7 CM
Hologic, Inc.
ASY-08176
In Commercial Distribution

  • 15420045506480 ()
  • 25420045506487 ()
ASY-08176

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506473

PADDLE, BIOPSY, STANDARD, 5 CM X 5 CM
Hologic, Inc.
ASY-08175
In Commercial Distribution

  • 15420045506473 ()
  • 25420045506470 ()
ASY-08175

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506466

PADDLE, BIOPSY, AXILLA, 5 CM X 5 CM
Hologic, Inc.
ASY-08174
In Commercial Distribution

  • 15420045506466 ()
  • 25420045506463 ()
ASY-08174

  • Mammographic stereotactic biopsy system

Digital Spot Mammography System, DSM - 15420045506077

No Description
Hologic, Inc.
3-000-2247
Not in Commercial Distribution

  • 15420045506077 ()
3-000-2247

  • Mammographic stereotactic biopsy system

Multicare Platinum - 15420045505926

No Description
Hologic, Inc.
8-004-0017
Not in Commercial Distribution

  • 15420045505926 ()
8-004-0017

  • Mammographic stereotactic biopsy system

Affirm Breast Biopsy Guidance System - 15420045505858

Affirm Breast Biopsy Guidance System
Hologic, Inc.
STLC-00004
In Commercial Distribution

  • 15420045505858 ()
STLC-00004

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045504738

AFFIRM SYSTEM, S/W 3D LICENSE
Hologic, Inc.
3D System Software
In Commercial Distribution

  • 15420045504738 ()
SW-04300

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045504721

No Description
Hologic, Inc.
System Software
In Commercial Distribution

  • 15420045504721 ()


  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE - 15420045504295

ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE
In Commercial Distribution

  • 15420045504295 ()
ATEC SAPPHIRE

  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE25 - 15420045504288

220V-50HZ ALL IN ONE BREAST BIOPSY SYSTEMS FOR BIOPS UNDER STEREOTATIC, ULTRASOND OR MRI GUIDNCE
Hologic, Inc.
ATEC SAPPHIRE25
In Commercial Distribution

  • 15420045504288 ()
ATEC SAPPHIRE25

  • Mammographic stereotactic biopsy system

ATEC Sapphire 200 - 15420045504110

200 ALL IN ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC Sapphire 200
In Commercial Distribution

  • 15420045504110 ()
ATEC SAPPHIRE 200

  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE 100 - 15420045504028

100 ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE 100
In Commercial Distribution

  • 15420045504028 ()
ATEC SAPPHIRE 100

  • Mammographic stereotactic biopsy system

Affirm® - 15420045518087

Affirm Breast Biopsy Guidance System
Hologic, Inc.
STLC-00004-CN
In Commercial Distribution

  • 15420045518087 ()
STLC-00004-CN

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045515161

Reusable Driver
Hologic, Inc.
BREVDRV-02
In Commercial Distribution

  • 15420045515161 ()
BREVDRV-02

  • Mammographic stereotactic biopsy system

BIOPSY DIGIT - 08033837190219

Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
BIOPSY DIGIT AM
In Commercial Distribution

  • 18033837190216 ()
  • 08033837190219 ()

  • Height: 347 Millimeter
  • Depth: 303 Millimeter
  • Width: 350 Millimeter
9100-01

  • Mammographic stereotactic biopsy system

TRIOS 3 - 05902768365511

A battery operated moving cart holding a processing unit/computer (PC) that drives the handheld scanner, power supplies and a display
3shape Trios A/S
TRIOS 3 battery cart
Not in Commercial Distribution

  • 05902768365511 ()


  • Dental milling system, CAD/CAM, chairside

Cassette 18cmx24cm(IP 18cmx24cm)Kit - 08809466040443

The Cassette 18cmx24cm(IP 18cmx24cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Digiray Corp.
CA06
In Commercial Distribution

  • 08809466040443 ()

  • Width: 18 Centimeter
  • Length: 24 Centimeter
  • Weight: 0.6 Kilogram


  • X-ray film cassette, manual

Cassette 24cmx30cm(IP 24cmx30cm)Kit - 08809466040436

The Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Digiray Corp.
CA05
In Commercial Distribution

  • 08809466040436 ()

  • Weight: 1.1 Kilogram
  • Length: 30 Centimeter
  • Width: 24 Centimeter


  • X-ray film cassette, manual

Cassette 35cmx43cm(IP 35cmx43cm)Kit - 08809466040429

The Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Digiray Corp.
CA04
In Commercial Distribution

  • 08809466040429 ()

  • Width: 35 Centimeter
  • Length: 43 Centimeter
  • Weight: 1.9 Kilogram


  • X-ray film cassette, manual

Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit - 08809466040030

The Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR.
Digiray Corp.
CA02
In Commercial Distribution

  • 08809466040030 ()

  • Width: 30 Centimeter
  • Length: 24 Centimeter
  • Weight: 1.5 Kilogram


  • X-ray film cassette, manual

Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit - 08809466040023

The Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR.
Digiray Corp.
CA01
In Commercial Distribution

  • 08809466040023 ()

  • Width: 35 Centimeter
  • Length: 43 Centimeter
  • Weight: 1.9 Kilogram


  • X-ray film cassette, manual

VITEK® MS SOFTWARE v1.1 - 03573026621698

The VITEK® MS Software is a computer application which supports the microbiology laboratory workflow for the VITEK® MS Systems.
BIOMERIEUX SA
VITEK MS SW V1.1
In Commercial Distribution

  • 03573026621698 ()


  • Microbial identification mass spectrometry system IVD

GIOTTO IMAGE 3DL - 08033837190035

MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
MAW
In Commercial Distribution

  • 08033837190035 ()
  • 18033837190032 ()

  • Height: 1920 Millimeter
  • Depth: 470 Millimeter
  • Width: 1175 Millimeter
6006-15GM3

  • Radiology DICOM image processing application software

NA - 06974813831363

Sinobot X1 Robotized image-guided interactive surgical equipment (including robotic arm, Display screen, Computer and software, Foot switch) 120 V - 60 Hz
Sinovation (Beijing) Medical Technology Co., Ltd
Sinobot X1
In Commercial Distribution

  • 06974813831363 ()


  • Neurological stereotactic surgery system

HeartVista Cardiac Package - B440HVCP030

HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution

  • B440HVCP030 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software

HeartVista Cardiac Package - B440HVCP020

HeartVista Cardiac Package
Heartvista, Inc.
020301
In Commercial Distribution

  • B440HVCP020 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software

MediPines Gas Exchange Monitor Starter Kit - 00860001261530

Breathing Circuit and Nose Clip, Single Use, 10 pieces each
MEDIPINES CORPORATION
MPSK10
In Commercial Distribution

  • 00860001261530 ()
  • 00860001261554 ()
MPSK10

  • Nose clip, single-use
  • Breathing mouthpiece, single-use

MediPines Single Patient Use Breathing Circuit - 00860001261516

Breathing Circuit Kit, Single Patient Use, 10
MEDIPINES CORPORATION
AGM316
In Commercial Distribution

  • 00860001261516 ()
  • 00860001261523 ()
  • 00860001261547 ()
  • 00860001261561 ()
AGM316-10, AGM316-50, AGM316-100

  • Breathing mouthpiece, single-use

HEMOSPHERE - 00690103199338

DPT OUT CABLE
Edwards Lifesciences LLC
HEMDPT1000
In Commercial Distribution

  • 00690103199338 ()

  • Length: 15.2 Inch
HEMDPT1000

  • Electrical-only medical device connection cable, reusable

FLOTRAC, VAMP, TRUWAVE - 00690103194760

FLOTRAC SENSOR WITH VAMP SYSTEM
Edwards Lifesciences LLC
MHD6C502
In Commercial Distribution

  • 00690103194760 ()
  • 50690103194765 ()

  • PRESSURE TUBING: 60 IN (152 CM) LENGTH, VAMP: 5 ML BLOOD RESERVOIR
MHD6C502

  • Invasive-pressure external transducer, single-use

FLOTRAC, TRUWAVE - 00690103194753

FLOTRAC SENSOR
Edwards Lifesciences LLC
MHD8C503
In Commercial Distribution

  • 00690103194753 ()
  • 50690103194758 ()

  • PRESSURE TUBING: 84 IN (213 CM) LENGTH
MHD8C503

  • Invasive-pressure external transducer, single-use

FLOTRAC, VAMP - 00690103194746

FLOTRAC SENSOR W/ VAMP ADULT (60"/152CM)
Edwards Lifesciences LLC
MHD6AZ5
In Commercial Distribution

  • 00690103194746 ()
  • 50690103194741 ()

  • PRESSURE TUBING: 60 IN (152 CM) LENGTH, VAMP: 5 ML BLOOD RESERVOIR
MHD6AZ5

  • Invasive-pressure external transducer, single-use

FLOTRAC - 00690103194739

FLOTRAC SENSOR
Edwards Lifesciences LLC
MHD8S102
In Commercial Distribution

  • 00690103194739 ()

  • PRESSURE TUBING: 84 IN (213 CM) LENGTH
MHD8S102

  • Invasive-pressure external transducer, single-use
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