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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OF 5 Panel, Cutoff -50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200176
In Commercial Distribution

  • 00810042683648 ()
18200176

  • Multiple drugs of abuse IVD, control
9 Panel Cutoff -/+ 25%, 5ML KITBOX
BIOCHEMICAL DIAGNOSTICS INC
18002907
In Commercial Distribution

  • 00810042680289 ()
18002907

  • Multiple drugs of abuse IVD, control
Top Sheet W/Clear Panel BNS
Cardinal Health 200, LLC
47187TNS
In Commercial Distribution

  • 50885380022874 ()
  • 10885380022876 ()
47187TNS

  • Patient surgical drape, single-use
For use the MMR IHC Panel
Ventana Medical Systems, Inc.
790-5094
In Commercial Distribution

  • 07613336100592 ()
07862261001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody
For use with MMR IHC Panel
Ventana Medical Systems, Inc.
790-5092
In Commercial Distribution

  • 07613336100578 ()
07862245001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MSH6 antigen IVD, antibody
Operating panel for table top II
Baxter Medical Systems GmbH + Co. KG
1549939
Not in Commercial Distribution

  • 00887761974517 ()


  • Operating room equipment remote control
Rapid Multi-drug Test Cup, 10 Panel
Guangzhou Decheng Biotechnology Co., LTD
4851U2X001
Not in Commercial Distribution

  • 06974464590152 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Multi-drug Test Dipcard -6 Panel
Guangzhou Decheng Biotechnology Co., LTD
4821D2X005
Not in Commercial Distribution

  • 06974464590121 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TR2810 Shower panel with thermostatic mixer
Tr Equipment AB
0520070-02
In Commercial Distribution

  • 07350016060110 ()


  • Bathing/changing table, mobile
Triage TOX Drug Screen (7 Panel)
QUIDEL CARDIOVASCULAR INC.
94404
Not in Commercial Distribution

  • 30014613337898 ()
94404

  • Multiple drugs of abuse IVD, kit, fluorescent immunoassay
Triage TOX Drug Screen (9 Panel)
QUIDEL CARDIOVASCULAR INC.
94402
Not in Commercial Distribution

  • 30014613337881 ()
94402

  • Multiple drugs of abuse IVD, kit, fluorescent immunoassay
Triage TOX Drug Screen (10 Panel)
QUIDEL CARDIOVASCULAR INC.
94401
Not in Commercial Distribution

  • 30014613337874 ()
94401

  • Multiple drugs of abuse IVD, kit, fluorescent immunoassay
25 tests kit; COC Single Panel
EASY HEALTHCARE CORPORATION
EDCO-114
In Commercial Distribution

  • 10810038631407 ()
  • 00810038631400 ()
  • 30810038631401 ()
EDCO-114-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Aptima® Mycoplasma genitalium Panel B.
HOLOGIC LTD.
KIT, M GEN PANEL B
In Commercial Distribution

  • 15420045509184 ()
PRD-03837

  • Mycoplasma genitalium nucleic acid IVD, reagent
ANTHEM FEMORAL TRIALS L PANEL SIZE1-6
Smith & Nephew, Inc.
71442135
In Commercial Distribution

  • 00885556613535 ()
71442135

  • Instrument tray, reusable
LEGION FEMORAL TRIALS L PANEL SIZE2-6
Smith & Nephew, Inc.
71442166
In Commercial Distribution

  • 00885556613528 ()
71442166

  • Instrument tray, reusable
ORTHOMATCH POSTERIOR STABILIZED PREPARATION PANEL SIZE1-8
Smith & Nephew, Inc.
71442168
In Commercial Distribution

  • 00885556613504 ()
71442168

  • Instrument tray, reusable
Detect Neg MIC Panel Type 1
Beckman Coulter, Inc.
B1020-100B
In Commercial Distribution

  • 15099590693404 ()
  • 05099590693407 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 79
Beckman Coulter, Inc.
B1017-431
In Commercial Distribution

  • 15099590658069 ()
  • 05099590658062 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 78
Beckman Coulter, Inc.
B1017-430
Not in Commercial Distribution

  • 15099590658052 ()
  • 05099590658055 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 77
Beckman Coulter, Inc.
B1017-429
In Commercial Distribution

  • 15099590658045 ()
  • 05099590658048 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 76
Beckman Coulter, Inc.
B1017-428
Not in Commercial Distribution

  • 15099590658038 ()
  • 05099590658031 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 75
Beckman Coulter, Inc.
B1017-427
In Commercial Distribution

  • 15099590658021 ()
  • 05099590658024 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 74
Beckman Coulter, Inc.
B1017-426
In Commercial Distribution

  • 15099590658014 ()
  • 05099590658017 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 73
Beckman Coulter, Inc.
B1017-423
In Commercial Distribution

  • 15099590657987 ()
  • 05099590657980 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Breakpoint Combo Panel Type 47
Beckman Coulter, Inc.
B1017-417
In Commercial Distribution

  • 15099590657932 ()
  • 05099590657935 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 62
Beckman Coulter, Inc.
B1017-416
In Commercial Distribution

  • 15099590657925 ()
  • 05099590657928 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 61
Beckman Coulter, Inc.
B1017-414
In Commercial Distribution

  • 15099590657918 ()
  • 05099590657911 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 60
Beckman Coulter, Inc.
B1017-413
In Commercial Distribution

  • 15099590657901 ()
  • 05099590657904 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Breakpoint Combo Panel Type 44
Beckman Coulter, Inc.
B1017-411
Not in Commercial Distribution

  • 15099590657888 ()
  • 05099590657881 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 55
Beckman Coulter, Inc.
B1017-409
In Commercial Distribution

  • 15099590657871 ()
  • 05099590657874 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Breakpoint Combo Panel Type 41
Beckman Coulter, Inc.
B1017-408
In Commercial Distribution

  • 15099590657864 ()
  • 05099590657867 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 51
Beckman Coulter, Inc.
B1017-407
In Commercial Distribution

  • 15099590657857 ()
  • 05099590657850 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg BP Combo Panel Type 34
Beckman Coulter, Inc.
B1017-404
In Commercial Distribution

  • 15099590657826 ()
  • 05099590657829 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg/Urine Combo Panel Type 46
Beckman Coulter, Inc.
B1017-403
In Commercial Distribution

  • 15099590657819 ()
  • 05099590657812 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Breakpoint Combo Panel Type 30
Beckman Coulter, Inc.
B1017-306
In Commercial Distribution

  • 15099590657680 ()
  • 05099590657683 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg/Urine Combo Panel Type 35
Beckman Coulter, Inc.
B1017-305
In Commercial Distribution

  • 15099590657673 ()
  • 05099590657676 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg/Urine Combo Panel Type 33
Beckman Coulter, Inc.
B1017-303
In Commercial Distribution

  • 15099590657659 ()
  • 05099590657652 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos BP Combo Panel Type 23
Beckman Coulter, Inc.
B1017-206
In Commercial Distribution

  • 15099590657475 ()
  • 05099590657478 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos BP Combo Panel Type 20
Beckman Coulter, Inc.
B1017-202
In Commercial Distribution

  • 15099590657406 ()
  • 05099590657409 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-113
Not in Commercial Distribution

  • 10849771035463 ()
  • 00849771035466 ()
  • 00849771044048 ()
  • 00849771032908 ()
SL113

  • Procedural medication labelling set
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-112
Not in Commercial Distribution

  • 00849771034810 ()
  • 00849771034803 ()
  • 00849771044031 ()
SL112

  • Procedural medication labelling set
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-105
Not in Commercial Distribution

  • 00849771033424 ()
  • 00849771033417 ()
  • 00849771043980 ()
SL105

  • Procedural medication labelling set
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-104
Not in Commercial Distribution

  • 00849771033400 ()
  • 00849771033394 ()
  • 00849771043973 ()
SL104

  • Procedural medication labelling set
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-109
Not in Commercial Distribution

  • 00849771033387 ()
  • 00849771033370 ()
  • 00849771044017 ()
SL109

  • Procedural medication labelling set
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-103
Not in Commercial Distribution

  • 00849771033363 ()
  • 00849771033356 ()
  • 00849771043966 ()
SL103

  • Procedural medication labelling set
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-101
Not in Commercial Distribution

  • 00849771043959 ()
  • 00849771033332 ()
SL101

  • Procedural medication labelling set
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-110
Not in Commercial Distribution

  • 10849771033162 ()
  • 00849771033165 ()
  • 00849771044024 ()
SL110

  • Procedural medication labelling set
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-107
Not in Commercial Distribution

  • 00849771032953 ()
  • 00849771032946 ()
  • 00849771044000 ()
SL107

  • Procedural medication labelling set
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-106
Not in Commercial Distribution

  • 00849771043997 ()
  • 00849771032137 ()
SL106

  • Procedural medication labelling set
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