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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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'1:1, Contra Angle(Button Type #2) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-03C
Saeshin Precision Co., Ltd.
X-CUBE #5
In Commercial Distribution

  • 08809260470828 ()


  • Dental power tool system, line-powered
1:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-01C
Saeshin Precision Co., Ltd.
X-CUBE #4
In Commercial Distribution

  • 08809260470811 ()


  • Dental power tool system, line-powered
Amplichek II Level 3 MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000578
In Commercial Distribution

  • 00847661005995 ()
12000578

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Level 2 MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000577
In Commercial Distribution

  • 00847661005988 ()
12000577

  • MRSA nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Amplichek II Level 1 MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000576
In Commercial Distribution

  • 00847661005971 ()
12000576

  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Amplichek II Negative MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000575
In Commercial Distribution

  • 00847661005964 ()
12000575

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Level 3 (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000204
In Commercial Distribution

  • 00847661005957 ()
12000204

  • MRSA nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Amplichek II Level 2 (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000203
In Commercial Distribution

  • 00847661005940 ()
12000203

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Level 1 (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000202
In Commercial Distribution

  • 00847661005933 ()
12000202

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Negative (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000201
In Commercial Distribution

  • 00847661005926 ()
12000201

  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
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