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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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MON 24950E MYCARELINK/SVC USA
MEDTRONIC, INC.
24950E
In Commercial Distribution

  • 00643169452060 ()


  • Cardiac pulse generator reader, home-use
MON 24950D MYCARELINK US M2.0
MEDTRONIC, INC.
24950D
Not in Commercial Distribution

  • 00643169441101 ()


  • Cardiac pulse generator reader, home-use
A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical coherence tomography.
OPTOS PUBLIC LIMITED COMPANY
P200TxE
In Commercial Distribution

  • 05057056107509 ()

  • Depth: 570 Millimeter
  • Width: 540 Millimeter
  • Height: 683 Millimeter
A10750

  • Scanning-laser ophthalmoscope/retinal optical coherence tomography system
The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retina, retinal nerve fiber layer and optic disc. The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, under mydriatic and non-mydriatic conditions. It is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps. The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.
OPTOS PUBLIC LIMITED COMPANY
P200TE
In Commercial Distribution

  • 05057056107004 ()
A10700

  • Scanning-laser ophthalmoscope/retinal optical coherence tomography system
No Description
OPTOS PUBLIC LIMITED COMPANY
A10688
In Commercial Distribution

  • 05057056106885 ()


  • Scanning-laser retinal imaging system
No Description
OPTOS PUBLIC LIMITED COMPANY
P200DTx
In Commercial Distribution

  • 05057056106502 ()
A10650

  • Scanning-laser retinal imaging system
No Description
OPTOS PUBLIC LIMITED COMPANY
A10639
In Commercial Distribution

  • 05057056106397 ()


  • Scanning-laser retinal imaging system
No Description
OPTOS PUBLIC LIMITED COMPANY
P200T
In Commercial Distribution

  • 05057056106007 ()
A10600

  • Scanning-laser retinal imaging system
No Description
OPTOS PUBLIC LIMITED COMPANY
200Tx
In Commercial Distribution

  • 05057056100920 ()
A10092

  • Scanning-laser retinal imaging system
No Description
OPTOS PUBLIC LIMITED COMPANY
P200C
In Commercial Distribution

  • 05057056100210 ()
A10021

  • Scanning-laser retinal imaging system
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