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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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HarmonyAIR - 00724995165956

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

HarmonyAIR - 00724995192204

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

HarmonyAIR - 00724995192112

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

HarmonyAIR - 00724995191979

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

HarmonyAIR - 00724995170509

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

HarmonyAIR - 00724995167257

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

HarmonyAIR - 00724995167165

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

HarmonyAIR - 00724995167011

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

HarmonyAIR - 00724995166069

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

HarmonyAIR - 00724995165963

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

HarmonyAIR - 00724995165734

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

HarmonyAIR - 00724995165666

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

HarmonyAIR - 00724995165635

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

HarmonyAIR - 00724995165628

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

HarmonyAIR - 00724995165574

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

CSI - 00850798007633

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

HarmonyAIR - 00724995199524

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

HarmonyAIR - 00724995199517

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

HarmonyAIR - 00724995199500

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

Forest - D0692502MCCG0

COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC-G
In Commercial Distribution

  • D0692502MCCG0 ()


  • Dental delivery system

Forest - D0692502MCCC0

COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC-C
In Commercial Distribution

  • D0692502MCCC0 ()


  • Dental delivery system

Forest - D0692502MCC0

COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC
In Commercial Distribution

  • D0692502MCC0 ()


  • Dental delivery system

LIFETEC - B866MLAM3501

STEEL, ELECTRIC, THREE SECTION, 27 IN WIDE TREATMENT TABLE WITH ADJUSTABLE HEAD SECTION, ADJUSTABLE FOOT SECTION, SIDE PANEL, AND CASTERS
ARMEDICA MANUFACTURING CORP.
LAM350
In Commercial Distribution

  • B866MLAM3501 ()
  • B866PLAM3501 ()
LAM350

  • Examination/treatment table, line-powered

Healgen (Private Label) 6125A3 - 00895330002851

Healgen (DrugConfirm) - 12 Panel AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50/Adulterants (CR/SG/OX)
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-6125A3C
In Commercial Distribution

  • 00895330002851 ()


  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

Healgen (Private Label) - 1145 - 00895330002585

Healgen (DrugConfirm) - 14 Panel Dip Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-1145
In Commercial Distribution

  • 00895330002585 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Methadone IVD, reagent
  • Nortriptyline IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

Vision-C 600 - 03615020000670

Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
ESSILOR INTERNATIONAL
VRS001
In Commercial Distribution

  • 03615020000670 ()


  • Visual acuity light box

X-MIND trium - D804W09000100

X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the left
DE GÖTZEN SRL
XMT PAN 3D L
Not in Commercial Distribution

  • D804W09000100 ()
W0900010

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital

X-MIND trium - D804W09000040

X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the right
DE GÖTZEN SRL
XMT PAN 3D R
Not in Commercial Distribution

  • D804W09000040 ()
W0900004

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital

Identify Health - 10850721007928

Identify Health 8 Panel Drug Test Cup CLIA Waived - 3.0mm Test Strip AMP500, BUP10, BZO300, COC150, EDDP300, MET500, MOP300, OXY100
MEDICAL DISTRIBUTION GROUP INC
ID-H8-1
In Commercial Distribution

  • 10850721007928 ()
  • 00850721007921 ()
ID-H8-1

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

Identify Health - 10850013035127

Identify Health 5 Panel Drug Test Cup - CLIA Waived COC150/MET500/OPI300/OXY100/THC50 3mm Strip, 25 Tests Per Box
MEDICAL DISTRIBUTION GROUP INC
ID-H5-1
In Commercial Distribution

  • 00850013035038 ()
  • 10850013035127 ()
ID-H5-1

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