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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A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Opgen, Inc.
KT03U01-2
Not in Commercial Distribution

  • 01812125010036 ()
KT03U01-2

  • Nucleic acid amplification mastermix kit IVD
A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Opgen, Inc.
KT03U01-2
Not in Commercial Distribution

  • 20812125010031 ()
KT03U01-2

  • Nucleic acid amplification mastermix kit IVD
The A-Series Dual Light, Single Flat Panel Monitor, No Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199524 ()
LAS02INNDA

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The A-Series Dual Light, Single Flat Panel Monitor, 20-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199517 ()
LAS02IN02A

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The A-Series Dual Light, Single Flat Panel Monitor, 13-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199500 ()
LAS02IN01A

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
The G5 Single Light Hybrid Extension, Non Camera, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192204 ()
LG22

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The G5 Dual Light with Single Flat Panel Monitor Mount, No Camera is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192112 ()
LG11

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Single Light with Single Flat Panel Monitor Mount, No Camera is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191979 ()
LG07

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Dual Spindle Dual Flat Panel Monitor CRT Light Head 11008909 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995170509 ()
LG00029

  • Medical monitor/light mount
The G5 Single Light Camera with Single Flat Panel Monitor Single Cardanic is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167257 ()
LGH38N

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The Single High Density M5 without Control with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166526 ()
LMH06N

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The Air Single M7 High Density with Single Flat Panel Monitor Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166069 ()
LMH09NT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Single Light Camera with ConnectPoint Express, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167165 ()
LGH14NCP

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Dual Variable No Camera Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167011 ()
LG41N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Dual High Density M5 without Control with two Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165963 ()
LMH03NT

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
The Dual High Density M5 without Control with two Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165956 ()
LMH03N

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The Air Dual M7/M5 High Density with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165734 ()
LMH08N

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The Single M5 without Control with Single Flat Panel Monitor, Spring Arm is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165666 ()
LM24N

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The Single High Density M5 without Control with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165635 ()
LMH04N

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The Dual High Density M5 without Control with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165628 ()
LMH02N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Touch Panel Control Unit Primary Dual Remote Power Module Set M-Series is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
Not in Commercial Distribution

  • 00724995165574 ()
LM0011

  • Medical monitor/light mount
Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and Image Processor.
OMEGA MEDICAL IMAGING, LLC
Soteria.AI
In Commercial Distribution

  • 00853901007025 ()


  • Stationary angiographic x-ray system, digital
CSI Cup - CLIA Screen In-Vitro 6 Panel Drug Test, Click Seal Cap, AMP, BZO, COC, MET, MOP, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-265
In Commercial Distribution

  • 00850798007633 ()
  • 00850798007640 ()
  • 00850798007657 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/BZO)
Instant Tech Subsidiary Acquisition
USSCupA-6MB
Not in Commercial Distribution

  • 00858998006159 ()
USSCupA-6MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The E-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214357 ()
LES14INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The E-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214340 ()
LES14IN02T

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The E-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214333 ()
LES14IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
HarmonyAIR A-Series High Density Single Adjustable Light 43-inch, Single Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203115 ()
LAH24A

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
A-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201111 ()
LAS14NCNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
A-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201104 ()
LAS14NC02T

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