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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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Magphan® 172, Complete Magphan® including 20cm spherical housing, 20cm cylindrical housing, 10cm test cube and cases.
Providus Holdings, Inc.
SMR172
In Commercial Distribution

  • 00812266030925 ()
SMR172

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
Magphan® 140, 10cm sphere with support disk.
Providus Holdings, Inc.
SMR140
In Commercial Distribution

  • 00812266030901 ()
SMR140

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
Magphan® 100, Complete Magphan® including 20cm spherical housing, 10cm test cube and case.
Providus Holdings, Inc.
SMR100
In Commercial Distribution

  • 00812266030895 ()
SMR100

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
Magphan® 170, Complete Magphan® including 20cm cylindrical housing, 10cm test cube and case.
Providus Holdings, Inc.
SMR170
In Commercial Distribution

  • 00812266030918 ()
SMR170

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
LiquiPhil™ End-to-End Pelvis, includes pelvis form, two 10cm ovoid tumor vessels and permanent storage case
Providus Holdings, Inc.
TLP260
In Commercial Distribution

  • 00812266030772 ()
TLP260

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside
Norav Receiver for wireless PC-ECG Acquisition Device Norav 1200W with ECG Trigger Output.
Norav Medical GmbH
1200WR
In Commercial Distribution

  • 04260498566907 ()
1200WR-D-00-09

  • Electrocardiographic signal amplifier
Safety Deluxe bone Marrow Biopsy/Aspiration Tray with Snare-it marrow acquisition & Aspiration needle
ROBERT BUSSE & CO., INC.
988
Not in Commercial Distribution

  • 10849233013831 ()
  • 00849233013834 ()
988

  • Bone marrow biopsy procedure kit
J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula 11g x4"
ROBERT BUSSE & CO., INC.
628
In Commercial Distribution

  • 00849233013179 ()
  • 10849233013176 ()
628

  • Bone marrow biopsy needle, single-use
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
VistaPano
Not in Commercial Distribution

  • 08800016401868 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
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