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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iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (AMP/BAR/BUP/BZO/COC/MET/OPI300/OXY/MTD/THC)
Instant Technologies, Inc.
I-DXP-2107-01
In Commercial Distribution

  • 00858945006829 ()
I-DXP-2107-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)
Instant Tech Subsidiary Acquisition
USSCupA-12NTCLIA
Not in Commercial Distribution

  • 00858998006135 ()
USSCupA-12NTCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BAR/BZO/PCP/MDMA/MTD/OXY/TCA)
Instant Tech Subsidiary Acquisition
USSCupA-12CLIA
Not in Commercial Distribution

  • 00858998006128 ()
USSCupA-12CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-12BUP300CLIA
Not in Commercial Distribution

  • 00858998006111 ()
USSCupA-12BUP300CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser.
RANDOX LABORATORIES LIMITED
EV3550
In Commercial Distribution

  • 05055273202458 ()
EV3550

  • Multiple drugs of abuse IVD, calibrator
CSI Cup - CLIA Screen In-Vitro 14 Panel Drug Test, Click Seal Cap, AMP500, BAR, BUP, BZO, COC150, mAMP500, MDMA, MOP300, MTD, OXY, PCP, PPX, TCA, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-1145S
In Commercial Distribution

  • 00850798007787 ()
  • 00850798007794 ()
  • 00850798007800 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CSI Cup - CLIA Screen In-Vitro 14 Panel Drug Test, CLICK SEAL CAP, AMP, BAR, BUP, BZO, COC, MET, MDMA, OPI, MTD, OXY, PCP, PPX, TCA, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-1144
In Commercial Distribution

  • 00850798007022 ()
  • 00850798007015 ()
  • 00850798007008 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The EZ Lift PowerLift Beach Chair, Left Shoulder Panel Pad, 3 inch TLT (Tri Layer Technology) provide excellent pressure management and are used with STERIS General Surgical Tables.
STERIS CORPORATION
BF00010
In Commercial Distribution

  • 00724995203542 ()
BF00010

  • Operating table mattress, basic
The EZ Lift PowerLift Beach Chair, Right Shoulder Panel Pad, 3 inch TLT (Tri Layer Technology) provide excellent pressure management and are used with STERIS General Surgical Tables.
STERIS CORPORATION
BF00009
In Commercial Distribution

  • 00724995203535 ()
BF00009

  • Operating table mattress, basic
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172886 ()
LES02NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172879 ()
LES02NC01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995172688 ()
LEH02INND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995172671 ()
LEH02IN02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995172664 ()
LEH02IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inchwith 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

  • 00724995173142 ()
LEH24IN01

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

  • 00724995172893 ()
LES02NCNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
Welch Allyn 767 Integrated Wall Diagnostic System including Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm)
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094068498 ()
76792-MNOBP

  • Basic power supply, reusable
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175955 ()
LES56NCND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175948 ()
LES56NC02

  • 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, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175931 ()
LES56NC01

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

  • 00724995175894 ()
LES13NCNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175887 ()
LES13NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175870 ()
LES13NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995175689 ()
LEH13INND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995175672 ()
LEH13IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995175665 ()
LEH13IN01

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

  • 00724995175658 ()
LES11NCNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175641 ()
LES11NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175634 ()
LES11NC01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995175443 ()
LEH11INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995175436 ()
LEH11IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995175429 ()
LEH11IN01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid High Definition 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

  • 00724995176044 ()
LEH56INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid High Definition 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

  • 00724995176037 ()
LEH56IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid High Definition 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

  • 00724995176020 ()
LEH56IN01

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

  • 00724995173616 ()
LES04NCNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inchwith Single Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173609 ()
LES04NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inchwith Single Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173593 ()
LES04NC01T

  • 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, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173555 ()
LES04NCND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition 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

  • 00724995173395 ()
LEH04IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition 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

  • 00724995173388 ()
LEH04IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, No Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173371 ()
LES24NCNDT

  • 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, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173364 ()
LES24NC02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light 43-inch with Single Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173296 ()
LES24NC01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inchwith 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

  • 00724995173166 ()
LEH24INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BAR/BZO/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12CLIA
Not in Commercial Distribution

USSCUPA-12CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12NTCLIA
In Commercial Distribution

USSCUPA12NTCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCupA-12BUP300CLIA
In Commercial Distribution

USSCUPA-12BUP30

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (AMP/BAR/BUP/BZO/COC/MET/OPI300/OXY/MTD/THC)
Instant Technologies, Inc.
I-DXP-2107-01
In Commercial Distribution

  • 00817405020355 ()
I-DXP-2107-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen™ Urine Test Visual X Drug Screen Cup 10 Panel with Adulterants E&I (OX/pH/CR)(AMP500/BAR300/BZO300/THC50/COC150/MTD300/MET500/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
TDOA-XC10A
In Commercial Distribution

  • 00817405021383 ()
  • 10817405021380 ()
TDOA-XC10A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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