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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The HarmonyAIR E-Series Hybrid High Definition Single Light, Dual Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168667 ()
LEH56

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168414 ()
LEH04

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The HarmonyAIR E-Series High Definition Single Light, 43-inch Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168391 ()
LEH24

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The HarmonyAIR Dual Light with Single Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172800 ()
LES02INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172794 ()
LES02IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172787 ()
LES02IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAir E-Series High Definition Dual Light, Single Flat Panel Monitor, Auxiliary is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995172145 ()
LEH03

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series Spindle Hybrid Single Light Dual Flat Panel Monitor High Definition is a ceiling supported lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995170981 ()
LEH000018

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173272 ()
LES24IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731958 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731941 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731934 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for(AMP/BZO/BUP/COC/OPI300/OXY/THC)
Instant Technologies, Inc.
I-DXP-177-01
In Commercial Distribution

  • 00858945006836 ()
I-DXP-177-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Phencyclidine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601594
Not in Commercial Distribution

  • 10690286000152 ()
  • 00690286000155 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605200
In Commercial Distribution

  • 00690286000483 ()
  • 10690286000480 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Cocaine, Amphetamine, and Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605104
In Commercial Distribution

  • 00690286000452 ()
  • 10690286000459 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Phencyclidine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601599
In Commercial Distribution

  • 00690286000346 ()
  • 10690286000343 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601638
Not in Commercial Distribution

  • 10690286000213 ()
  • 00690286000216 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY,PCP,TCA,THC with 3 AD (+pH, OX,SG)
MERCEDES MEDICAL, LLC
TNR CDOA7125A3
In Commercial Distribution

  • 00850011007112 ()
  • 10850011007119 ()
  • 20850011007116 ()
TNR CDOA7125A3

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1 Ply Body, 2 Ply Front Pocket Panel, Misty, 21 3/4 x 44
STANDARD TEXTILE CO., INC.
95301682
In Commercial Distribution

  • 00634916000016 ()
  • 10634916000013 ()
95301682

  • Patient surgical drape, reusable
X-MIND trium PAN CBCT including one removable pan sensor and a CBCT sensor, with control panel on the left and ceph arm on the left
DE GÖTZEN SRL
XMT PAN 3D L CEPH L
Not in Commercial Distribution

  • D804W09002330 ()
W0900233

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT including one removable pan sensor and a CBCT sensor, with control panel on the left and ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D L CEPH R
Not in Commercial Distribution

  • D804W09000120 ()
W0900012

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/TCA/BUP with Adulteration strip (OX/S.G./CRE/PH)
UCP BIOSCIENCES, INC.
U-DUD-10124-RCN
In Commercial Distribution

  • 20817038020634 ()
  • 10817038020637 ()
  • 00817038020630 ()
U-DUD-10124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Drug Test Panel (8.25) AMP1000 BAR300 BZO300 COC300 MET1000 OPI2000 PCP25 THC50. For the detection of drugs in human urine. 25 tests/kit.
BTNX Inc
D8.25-1P29-25
In Commercial Distribution

  • 00722066005651 ()
  • 10722066005658 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 14 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/PPX/TCA/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-13147-0-A
In Commercial Distribution

  • 00816036025159 ()
  • 00816036025319 ()
STATⅡ-13147-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel CLIA Waived Click Cup w/ SVT AMP500, BAR300, BUP10, BZO300, COC150, MDMA500, MET500, MOP300, MTD300, OXY100, PCP25, THC50 w/ SVT OX/SG/pH
Instant Technologies, Inc.
ABTDUAW112706F
In Commercial Distribution

  • 30817405023838 ()
  • 00817405023837 ()
  • 10817405023834 ()
ABTDUAW112706F

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel CLIA Waived Flat Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, THC50 w/ SVT CR/SG/Ph
Instant Technologies, Inc.
ABTDUAW112705E
In Commercial Distribution

  • 30817405023814 ()
  • 00817405023813 ()
  • 10817405023810 ()
ABTDUAW112705E

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Screen for AMP1000, COC300, MET1000, OPI2000, THC50
Instant Technologies, Inc.
I-DXP-5M
In Commercial Distribution

  • 00817405021079 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Screen for AMP1000, COC300, OPI2000, PCP25, THC50
Instant Technologies, Inc.
I-DXP-5A
In Commercial Distribution

  • 00817405021055 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for(AMP/BZO/BUP/COC/OPI300/OXY/THC)
Instant Technologies, Inc.
I-DXP-177-01
In Commercial Distribution

  • 00817405020287 ()
I-DXP-177-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP1000)+BUP with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-13M
Not in Commercial Distribution

  • 00816565020304 ()
IMCA-13M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
175785
In Commercial Distribution

  • 10768455102591 ()
  • 00768455102594 ()
  • 00768455181315 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
175779
In Commercial Distribution

  • 10768455102539 ()
  • 00768455102532 ()
  • 00768455181254 ()


  • One-piece intestinal ostomy bag, open-ended
13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50 3mm Strip - 25 Pack Box.
MEDICAL DISTRIBUTION GROUP INC
ID-H13-1
Not in Commercial Distribution

  • 01085072100710 ()
  • 00850721007105 ()
ID-H13-1

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175924 ()
LES56INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175900 ()
LES56IN01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175856 ()
LES13IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175610 ()
LES11IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inchwith Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173586 ()
LES04INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inch with Single Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173524 ()
LES04INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inch with Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173517 ()
LES04IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inch with Single Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173500 ()
LES04IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175917 ()
LES56IN02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175863 ()
LES13INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175849 ()
LES13IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175627 ()
LES11INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175603 ()
LES11IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172862 ()
LES02INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172855 ()
LES02IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172848 ()
LES02IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
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