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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No Description
BIOPRO, INC.
21130
In Commercial Distribution

  • M209211300 ()


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
No Description
BIOPRO, INC.
21129
In Commercial Distribution

  • M209211290 ()


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution

  • 04987669100530 ()


  • Optical pachymeter
  • Direct ophthalmoscope, line-powered
Universal Dentin Sealant Mini Kit Universal
ULTRADENT PRODUCTS, INC.
1020
Not in Commercial Distribution

  • 00883205104014 ()
1020

  • Dental coating, tooth-desensitizing
Universal Dentin Sealant Kit
ULTRADENT PRODUCTS, INC.
265
In Commercial Distribution

  • 00883205103338 ()
265

  • Dental coating, tooth-desensitizing
Universal Dentin Sealant Refill Universal
ULTRADENT PRODUCTS, INC.
266
In Commercial Distribution

  • 00883205103321 ()
266

  • Dental coating, tooth-desensitizing
Enamelast 0.4ml Syringe 200pk - Walterberry
ULTRADENT PRODUCTS, INC.
4531
In Commercial Distribution

  • 00883205103314 ()
4531

  • Dental coating, tooth-desensitizing
UltraEZ Syringe Kit
ULTRADENT PRODUCTS, INC.
1008
In Commercial Distribution

  • 00883205103086 ()
1008

  • Dental coating, tooth-desensitizing
UltraEZ Syringe Econo Kit
ULTRADENT PRODUCTS, INC.
1007
In Commercial Distribution

  • 00883205103079 ()
1007

  • Dental coating, tooth-desensitizing
Enamelast Syringe 20pk - Bubble Gum
ULTRADENT PRODUCTS, INC.
4367
Not in Commercial Distribution

  • 00883205102911 ()
4367

  • Dental coating, tooth-desensitizing
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