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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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RIVAL TI MTP PLATE MEDIUM (present record replaces device with Primary DI: 18053800893364
ORTHOFIX SRL
2
In Commercial Distribution

  • 18053340340885 ()
002-B-02002

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
RIVAL TI MTP PLATE SMALL (present record replaces device with Primary DI: 18053800893357
ORTHOFIX SRL
2
In Commercial Distribution

  • 18053340340878 ()
002-B-01001

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Telephone electrocardiograph transmitter and receiver
UNIVERSAL MEDICAL, INC.
Heartrak 2
In Commercial Distribution

  • B147HT20 ()


  • Electrocardiography telemetric monitoring system
Single-Fill Composite System; Intro Kit
Kerr Corporation
36044
In Commercial Distribution

  • 10841396116404 ()
  • 00841396116407 ()

  • Weight: 15 Gram
36044

  • Light-cured dental restorative composite resin
Single-Fill Composite System; Value Kit
Kerr Corporation
36043
In Commercial Distribution

  • 10841396116398 ()
  • 00841396116391 ()

  • Weight: 75 Gram
36043

  • Light-cured dental restorative composite resin
SingleFill Composite System; Composite Material; Unidose; B1; Refill
Kerr Corporation
36054
In Commercial Distribution

  • 10841396115940 ()
  • 00841396115943 ()

  • Weight: 5 Gram
36054

  • Light-cured dental restorative composite resin
SingleFill Composite System; Composite Material; Unidose; A3; Refill
Kerr Corporation
36053
In Commercial Distribution

  • 10841396115933 ()
  • 00841396115936 ()

  • Weight: 5 Gram
36053

  • Light-cured dental restorative composite resin
SingleFill Composite System; Composite Material; Unidose; A2; Refill
Kerr Corporation
36052
In Commercial Distribution

  • 10841396115926 ()
  • 00841396115929 ()

  • Weight: 5 Gram
36052

  • Light-cured dental restorative composite resin
SingleFill Composite System; Composite Material; Unidose; A1; Refill
Kerr Corporation
36051
In Commercial Distribution

  • 10841396115919 ()
  • 00841396115912 ()

  • Weight: 5 Gram
36051

  • Light-cured dental restorative composite resin
MultiPurpose Instrument Cleaner Polisher and Cart Washer Agent
METREX RESEARCH, LLC
10-8130
In Commercial Distribution

  • 00615375005767 ()

  • Total Volume: 30 Gallon


  • Medical device-decontamination agent
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