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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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SHOFU BLOCK HC M A1-LT (10 PCS)
SHOFU DENTAL CORPORATION
2158B
In Commercial Distribution

  • E2352158B9 ()
  • E2352158B1 ()
2158B

  • Dental milling system, CAD/CAM, chairside
SHOFU BLOCK HC M A1-LT (5 PCS)
SHOFU DENTAL CORPORATION
2158
In Commercial Distribution

  • E23521580 ()
  • E23521581 ()
2158

  • Dental milling system, CAD/CAM, chairside
SHOFU BLOCK HC M for Ceramill
SHOFU DENTAL CORPORATION
2157B
In Commercial Distribution

  • E2352157B9 ()
  • E2352157B1 ()
2157B

  • Dental milling system, CAD/CAM, chairside
SHOFU BLOCK HC M W2-LT (5 PCS)
SHOFU DENTAL CORPORATION
2157
In Commercial Distribution

  • E23521570 ()
  • E23521571 ()
2157

  • Dental milling system, CAD/CAM, chairside
fastscan.io Wireless Intraoral Scanner
Prismatik Dentalcraft, Inc
70-1181-MIL0153
Not in Commercial Distribution

  • D745701181MIL01530 ()
70-1181-MIL0153

  • Dental milling system, CAD/CAM, chairside
fastscan.io Intraoral Scanner
Prismatik Dentalcraft, Inc
70-1181-MIL0152
Not in Commercial Distribution

  • D745701181MIL01520 ()
70-1181-MIL0152

  • Dental milling system, CAD/CAM, chairside
No Description
Dental Wings Inc
DWIO001
In Commercial Distribution

  • D840DWIO0010 ()

  • Width: 510 Millimeter
  • Height: 1370 Millimeter
  • Length: 600 Millimeter


  • Dental milling system, CAD/CAM, chairside
Meditherm Iris Digital Thermal Camera
Meditherm Incorporated
IRIS 640
In Commercial Distribution

  • B783706400170601151 ()
1706400

  • Infrared thermography system
No Description
BRAEMAR MANUFACTURING, LLC
900-0612-04
In Commercial Distribution

  • B146ERWCD040 ()


  • Electrocardiographic ambulatory recorder
ePatch Holter Device
BRAEMAR MANUFACTURING, LLC
900-0630-00
In Commercial Distribution

  • B146EP010 ()


  • Electrocardiographic ambulatory recorder
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