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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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4 Lead Holter Cable
Tz Medical, Inc.
H3R-0077
In Commercial Distribution

  • 00811331013993 ()


  • Telemetric electrocardiographic ambulatory recorder
3-Lead LTE MCT Monitor ZOLL
Tz Medical, Inc.
H3R-0161
In Commercial Distribution

  • 00811331011562 ()


  • Telemetric electrocardiographic ambulatory recorder
3 Lead MCT Monitor Zoll Variant
Tz Medical, Inc.
H3R-0154
In Commercial Distribution

  • 00811331011555 ()


  • Telemetric electrocardiographic ambulatory recorder
3 Lead MCT Monitor GMed Variant
Tz Medical, Inc.
H3R-0133
In Commercial Distribution

  • 00811331011531 ()


  • Telemetric electrocardiographic ambulatory recorder
Gang Charger for 9 Holter Devices
Tz Medical, Inc.
H3R-0073
In Commercial Distribution

  • 00811331010527 ()


  • Telemetric electrocardiographic ambulatory recorder
Trident 40M
Tz Medical, Inc.
H3R-0040
In Commercial Distribution

  • 00811331010268 ()


  • Telemetric electrocardiographic ambulatory recorder
H3R 3-Lead Holter Recorder
Tz Medical, Inc.
H3R-0039
In Commercial Distribution

  • 00811331010251 ()


  • Telemetric electrocardiographic ambulatory recorder
3-Lead LTE MCT Monitor GMED
Tz Medical, Inc.
H3R-0164
In Commercial Distribution

  • 00811331010060 ()


  • Telemetric electrocardiographic ambulatory recorder
Hysteroscopy Pack
Aligned Medical Solutions
AMS1985B
In Commercial Distribution

  • B098AMS1985B1 ()
  • B098AMS1985B0 ()
AMS1985B

  • Rectal ultrasound navigational image processor
Wireless Imaging System
FORESEESON CUSTOM DISPLAYS, INC.
WUH4060
In Commercial Distribution

  • 00810000890569 ()
WUH4060

  • Medical networking interface unit
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