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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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Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-90
In Commercial Distribution

  • 00884999003071 ()
2N40-90

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Microplasty Tibial Template Left Medial
Biomet Uk Ltd
32-422854
In Commercial Distribution

  • 05019279403899 ()

  • B
32-422854

  • Surgical implant template, reusable
Microplasty Tibial Template Right Medial
Biomet Uk Ltd
32-422853
In Commercial Distribution

  • 05019279403882 ()

  • B
32-422853

  • Surgical implant template, reusable
SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
Stockert GmbH
M490023
In Commercial Distribution

  • 04260166371345 ()


  • Electrical-only medical device connection cable, reusable
SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 3 m
Stockert GmbH
M490021
In Commercial Distribution

  • 04260166371352 ()


  • Electrical-only medical device connection cable, reusable
USA manufactured control kit
Diasorin Inc.
311021
In Commercial Distribution

  • 08056771602952 ()


  • Interferon gamma release IVD, control
No Description
DIASORIN SPA
311021
In Commercial Distribution

  • 08056771103275 ()


  • Interferon gamma release IVD, control
Skin-Port-LANG B
ASPIRE BARIATRICS, INC.
200-0011-LANG B
In Commercial Distribution

  • 10857808005273 ()
200-0011-LANG B

  • Gastrostomy aspiration system gravity set
Connector-LANG B
ASPIRE BARIATRICS, INC.
200-0019-LANG B
In Commercial Distribution

  • 10857808005068 ()
  • 20857808005065 ()
200-0019-LANG B

  • Gastrostomy aspiration system gravity set
3100B Ventilator 3rd Edition
Carefusion Corporation
22348-801
Not in Commercial Distribution

  • 10846446005868 ()
22348-801

  • Stationary electric high-frequency ventilator
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