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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 - 00724995200305

The A-Series Single Light 35-inch, Single Flat Panel Monitor, No Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200305 ()
LAS04INNDTA

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

HarmonyAIR - 00724995200299

The A-Series Single Light 35-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200299 ()
LAS04IN02TA

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

HarmonyAIR - 00724995200282

The A-Series Single Light 35-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200282 ()
LAS04IN01TA

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

HarmonyAIR - 00724995200275

The A-Series Single Light 35-inch, Single Flat Panel Monitor, No Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200275 ()
LAS04NCNDA

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

HarmonyAIR - 00724995200268

The A-Series Single Light 35-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200268 ()
LAS04NC02A

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

HarmonyAIR - 00724995200251

The A-Series Single Light 35-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200251 ()
LAS04NC01A

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

HarmonyAIR - 00724995200060

The A-Series Single Light 43-inch, Single Flat Panel Monitor, No Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200060 ()
LAS24INNDTA

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

HarmonyAIR - 00724995200053

The A-Series Single Light 43-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200053 ()
LAS24IN02TA

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

HarmonyAIR - 00724995200046

The A-Series Single Light 43-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200046 ()
LAS24IN01TA

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

HarmonyAIR - 00724995200039

The A-Series Single Light 43-inch, Single Flat Panel Monitor, No Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200039 ()
LAS24NCNDA

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

HarmonyAIR - 00724995200022

The A-Series Single Light 43-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200022 ()
LAS24NC02A

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

HarmonyAIR - 00724995200015

The A-Series Single Light 43-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200015 ()
LAS24NC01A

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

HarmonyAIR - 00724995199616

The A-Series Dual Light, Single Flat Panel Monitor, No Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199616 ()
LAS02NCNDTA

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

HarmonyAIR - 00724995199609

The A-Series Dual Light, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199609 ()
LAS02NC02TA

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

HarmonyAIR - 00724995199593

The A-Series Dual Light, Single Flat Panel Monitor, 13-inch Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199593 ()
LAS02NC01TA

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

HarmonyAIR - 00724995199401

The A-Series High Definition 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

  • 00724995199401 ()
LAH02INNDA

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

HarmonyAIR - 00724995199395

The A-Series High Definition 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

  • 00724995199395 ()
LAH02IN02A

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

HarmonyAIR - 00724995199388

The A-Series High Definition 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

  • 00724995199388 ()
LAH02IN01A

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

HarmonyAIR - 00724995192471

The G5 Dual Lights with Single Flat Panel Monitor, High Density Camera and ConnectPoint is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995192471 ()
LGH51CP

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

HarmonyAIR - 00724995192457

The G5 Dual Light with Dual Single Flat Panel Monitor, High Density Camera Ready is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995192457 ()
LGH51

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

HarmonyAIR - 00724995192396

The G5 Dual Light with Single Flat Panel Monitor Mount, High Density Camera Ready is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192396 ()
LGH12

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

HarmonyAIR - 00724995192334

The G5 Single Light, Single Flat Panel Monitor, High Density Camera Ready and ConnectPoint is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192334 ()
LGH14CP

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

HarmonyAIR - 00724995192273

The G5 Single Light with Single Flat Panel Monitor Mount, High Density Camera Ready is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192273 ()
LGH08

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

HarmonyAIR - 00724995192129

The G5 Dual Light with Single Flat Panel Monitor Mount, No Camera with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192129 ()
LG11T

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

HarmonyAIR - 00724995192013

The G5 S Light with Single Flat Panel Monitor Mount, Non Camera, Single Cardanic is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192013 ()
LG37

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

HarmonyAIR - 00724995191986

The G5 Single Light with Single Flat Panel Monitor Mount, No Camera with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191986 ()
LG07T

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

HarmonyAIR - 00724995191818

The M7/M5 High Density Package, Single Flat Panel Monitor Mount, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191818 ()
LMH08

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

HarmonyAIR - 00724995191771

The M7 Single High Density Package with Hub Spacer, Single Flat Panel Monitor Mount is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191771 ()
LMH29

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

HarmonyAIR - 00724995191764

The M7 Single High Density Package, No Hub, Single Flat Panel Monitor Mount, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191764 ()
LMH09T

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

HarmonyAIR - 00724995191696

The M7 Single Package with Single High Density Flat Panel Monitor Mount, with Hub is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191696 ()
LM29

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

HarmonyAIR - 00724995191672

The M7 Single Package with Single High Density Flat Panel Monitor Mount, No Hub is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191672 ()
LM09

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

HarmonyAIR - 00724995191573

The M5 High Density Dual Package, Single Flat Panel Monitor Mount, without/Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191573 ()
LMH02T

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

HarmonyAIR - 00724995191566

The M5 High Density Dual Package, Single Flat Panel Monitor Mount, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191566 ()
LMH02

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

HarmonyAIR - 00724995191528

The M5 High Density Single Package with Hub Spacer, Single Flat Panel Monitor Mount is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191528 ()
LMH24

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

HarmonyAIR - 00724995191511

The M5 High Density Single Package No Hub, Single Flat Panel Monitor Mount, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191511 ()
LMH04T

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

HarmonyAIR - 00724995191504

The M5 High Density Single Package No Hub Spacer, Single Flat Panel Monitor Mount is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191504 ()
LMH04

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

HarmonyAIR - 00724995191450

The M5, Dual Package with two Single Flat Panel Monitor Mount, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191450 ()
LM03

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

HarmonyAIR - 00724995191443

The M5, Dual Package with Single Flat Panel Monitor Mount, without/Hub Spacer, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191443 ()
LM02T

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

HarmonyAIR - 00724995190491

The M7 Single High Density Package with Hub Spacer, 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

  • 00724995190491 ()
LMH29NT

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

HarmonyAIR - 00724995190484

The M7 SGL High Density Package with Hub Spacer and Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190484 ()
LMH29N

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

HarmonyAIR - 00724995190477

The M7 Single Package with Single High Density Flat Panel Monitor with Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190477 ()
LM29NT

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

u-Card Drug Test Screen - 10817038021368

12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC with Adulteration strip(S.G./CRE/ pH)
UCP BIOSCIENCES, INC.
U-DUD-6124L
In Commercial Distribution

  • 20817038021365 ()
  • 10817038021368 ()
  • 00817038021361 ()
U-DUD-6124L

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

UCP Home Drug Screening Test Cups - 10817038021627

UCP Home Drug Screening Test Cups 10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/PCP/AMP
UCP BIOSCIENCES, INC.
U-CUP-6104-RCN
In Commercial Distribution

  • 20817038021624 ()
  • 10817038021627 ()
  • 00817038021620 ()
U-CUP-6104-RCN

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

u-Cup Drug Test Screen - 10817038021184

12 Panel Drug Test Cup W/AD AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC(S.G., CRE,pH)
UCP BIOSCIENCES, INC.
U-DUD-6124
In Commercial Distribution

  • 20817038021181 ()
  • 10817038021184 ()
  • 00817038021187 ()
U-DUD-6124

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

u-Cup Drug Test Screen - 10817038021108

12 Panel Drug Test Cup W/AD AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC)(S.G., CRE,pH)
UCP BIOSCIENCES, INC.
U-DUD-20124
In Commercial Distribution

  • 20817038021105 ()
  • 10817038021108 ()
  • 00817038021101 ()
U-DUD-20124

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

iCup® - 10817405021342

iCup® E&I Urine Test 6 Panel Drug Screen Cup w/SVT (CR/pH/SG) (AMP1000/COC300/MET1000/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
DPG-167-1202
In Commercial Distribution

  • 00817405021345 ()
  • 10817405021342 ()
DPG-167-1202

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

SkyVision - 10841736111724

SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Panel, Optical Router, IP addressable Control Switch and On-Board Uninterruptable Power Supply.
SKYTRON LLC
LINX 300
In Commercial Distribution

  • 10841736111724 ()
SVIS-LINX

  • Radiology picture archiving and communication system digital archive device

T2Candida® 1.1 Cartridge Kit - M70890078170

The T2Candida 1.1 Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
90-07817
In Commercial Distribution

  • M70890078170 ()


  • Multiple Candida species nucleic acid IVD, reagent

X-MIND trium - D804W09002300

X-MIND trium PAN CEPH version including one removable ceph sensor, with control panel on the right and ceph arm on the right
DE GÖTZEN SRL
XMT PAN R CEPH R
Not in Commercial Distribution

  • D804W09002300 ()
W0900230

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

X-MIND trium - D804W09002260

X-MIND trium PAN T version including one removable pan sensor with control panel on the left configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN 3D READY L
Not in Commercial Distribution

  • D804W09002260 ()
W0900226

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