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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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Tomo/3Dimaging lesion marker, 10mm triangle,100/box https://xactmarkers.com/product/tomography-lesion-markers-2/
Solstice Corporation
M10TT
In Commercial Distribution

  • 10854623006010 ()
  • 00854623006013 ()
M10TT

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use
X-ray metal BB marker, 1.5mm diameter, lead free,120/box https://xactmarkers.com/product/nipple-markers-bb-markers-for-radiology-m15s/
Solstice Corporation
M15S
In Commercial Distribution

  • 10854623006003 ()
  • 00854623006006 ()
M15S

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use
No Description
CLEAR GUIDE MEDICAL, INC.
CGTT
In Commercial Distribution

  • B201CGTT1 ()
  • B201CGTT0 ()
  • B201CGTT2 ()


  • Imaging lesion localization marker, external, single-use
  • Surgical optical-tracking spatial marker, single-use
OTE/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used to mitigate mild to severe hearing losses and can be programmed with software to tailor to user needs.
Persona Medical
Sombra 9P
In Commercial Distribution

  • 00851362008568 ()


  • Air-conduction hearing aid, behind-the-ear
OTE/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used to mitigate mild to severe hearing losses and can be programmed with software to tailor to user needs.
Persona Medical
Sombra 9S
In Commercial Distribution

  • 00851362008537 ()


  • Air-conduction hearing aid, behind-the-ear
RIC/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used to mitigate mild to severe hearing losses and can be programmed with software to tailor to user needs.
Persona Medical
Sombra 9R
In Commercial Distribution

  • 00851362008520 ()


  • Air-conduction hearing aid, behind-the-ear
QUASAR MRgRT Insight (MRDQA) Phantom - Support Base Package. Includes Support base and upright sections with 1 laser alignment target, User’s Guide, Heavy Duty Case, and software for 1 MR scanner with unlimited scans.
Modus Medical Devices Inc
100-1023-100
In Commercial Distribution

  • G34310010231000 ()


  • Multi-modality therapeutic radiation phantom, test object
The BOND System Control Kit provides the computer which contains the software (version 7.0) that controls the Processing Modules(s), as well as the Slide Labeler, Handheld barcode scanner, ethernet switch and power cable.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND System Control Kit (version 7)
In Commercial Distribution

  • 09349458005504 ()
49.0644

  • Microscope slide stainer IVD
BOND Mixing Station contains six cavities that are used to mix shortlife reagents that must be mixed just before use. The mixing of the reagents is determined by the software, depending on reagent type.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Mixing Stations (5 pack)
In Commercial Distribution

  • 09349458001261 ()
S21.1971

  • Microscope slide stainer IVD
The CellaVision Server Software is a network optimization design to create workflow efficency in lager organizations and enables easy data transfer from all connected analyzers to a centralized database residing on a single server.
Cellavision AB
CSS-0000NG
In Commercial Distribution

  • 07350040976036 ()
CSS-0000NG

  • Medical networking interface unit
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