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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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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™ CONTRAST BIOPSY - 15420045512948

Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices.
Hologic, Inc.
AFFIRM™ CONTRAST BIOPSY SOFTWARE
In Commercial Distribution

  • 15420045512948 ()
CMP-01771

  • Mammographic stereotactic biopsy system

AFFIRM™ SPECIMEN IMAGING - 15420045512931

No Description
Hologic, Inc.
AFFIRM™ SPECIMEN IMAGING
In Commercial Distribution

  • 15420045512931 ()


  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045512863

Single-use, disposable needle for acquiring biopsy specimens.
Hologic, Inc.
BREVDISP09
In Commercial Distribution

  • 15420045512863 ()
  • 15420045512870 ()
BREVDISP09

  • Mammographic stereotactic biopsy system

Audyx - 07290017820019

Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution

  • 07290017820019 ()
N/A

  • Tone audiometer

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

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

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
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