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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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Hologic, Inc.
8-004-0017
Not in Commercial Distribution

  • 15420045505926 ()
8-004-0017

  • Mammographic stereotactic biopsy system
Affirm Breast Biopsy Guidance System
Hologic, Inc.
STLC-00004
In Commercial Distribution

  • 15420045505858 ()
STLC-00004

  • Mammographic stereotactic biopsy system
Affirm Breast Biopsy Guidance System
Hologic, Inc.
STLC-00004-CN
In Commercial Distribution

  • 15420045518087 ()
STLC-00004-CN

  • Mammographic stereotactic biopsy system
Reusable Driver
Hologic, Inc.
BREVDRV-02
In Commercial Distribution

  • 15420045515161 ()
BREVDRV-02

  • Mammographic stereotactic biopsy system
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
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
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
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
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
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
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