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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 - 00724995176143

The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 13-inch Drop Tube, No Camera is a ceiling supported suspension system.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176143 ()
LES57NC01

  • Medical monitor/light mount

HarmonyAIR - 00724995200244

The A-Series Single Light 35-inch, 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

  • 00724995200244 ()
LAS04INNDA

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

HarmonyAIR - 00724995200237

The A-Series Single Light 35-inch, 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

  • 00724995200237 ()
LAS04IN02A

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

HarmonyAIR - 00724995200220

The A-Series Single Light 35-inch, 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

  • 00724995200220 ()
LAS04IN01A

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

HarmonyAIR - 00724995200008

The A-Series Single Light 43-inch, 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

  • 00724995200008 ()
LAS24INNDA

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

HarmonyAIR - 00724995199999

The A-Series Single Light 43-inch, 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

  • 00724995199999 ()
LAS24IN02A

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

HarmonyAIR - 00724995199982

The A-Series Single Light 43-inch, 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

  • 00724995199982 ()
LAS24IN01A

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

HarmonyAIR - 00724995199586

The A-Series Dual Light, 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

  • 00724995199586 ()
LAS02INNDTA

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

HarmonyAIR - 00724995199579

The A-Series Dual Light, 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

  • 00724995199579 ()
LAS02IN02TA

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

HarmonyAIR - 00724995199562

The A-Series Dual Light, 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

  • 00724995199562 ()
LAS02IN01TA

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

HarmonyAIR - 00724995199555

The A-Series Dual Light, 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

  • 00724995199555 ()
LAS02NCNDA

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

HarmonyAIR - 00724995199548

The A-Series Dual Light, 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

  • 00724995199548 ()
LAS02NC02A

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

HarmonyAIR - 00724995199531

The A-Series Dual Light, 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

  • 00724995199531 ()
LAS02NC01A

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

HarmonyAIR - 00724995199197

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

  • 00724995199197 ()
LG41

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

HarmonyAIR - 00724995192136

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

  • 00724995192136 ()
LG11F

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

HarmonyAIR - 00724995191993

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

  • 00724995191993 ()
LG07F

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

HarmonyAIR - 00724995191757

The M7 Single High Density Package No Hub, 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

  • 00724995191757 ()
LMH09

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

HarmonyAIR - 00724995191436

The M5, Dual Package with 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

  • 00724995191436 ()
LM02

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

HarmonyAIR - 00724995191405

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

  • 00724995191405 ()
LM24T

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

HarmonyAIR - 00724995191399

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

  • 00724995191399 ()
LM24

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

HarmonyAIR - 00724995191382

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

  • 00724995191382 ()
LM04T

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

HarmonyAIR - 00724995191375

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

  • 00724995191375 ()
LM04

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

HarmonyAIR - 00724995190460

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

  • 00724995190460 ()
LM29N

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

u-Cup - 10817038021412

10 Panel Drug Test Cup BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC with Adulteration strip(S.G.,CRE, pH)
UCP BIOSCIENCES, INC.
U-DUD-7104
In Commercial Distribution

  • 20817038021419 ()
  • 10817038021412 ()
  • 00817038021415 ()
U-DUD-7104

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

iScreen™ - 10817405021328

iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/TCA/THC)
Instant Technologies, Inc.
IS12BUP-DX2
In Commercial Distribution

  • 00817405021321 ()
  • 10817405021328 ()
IS12BUP-DX2

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

iScreen™ - 10817405021311

iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/TCA/THC)
Instant Technologies, Inc.
IS12-DX2
In Commercial Distribution

  • 00817405021314 ()
  • 10817405021311 ()
IS12-DX2

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

Platinum+ - 00850011007570

Platinum+ Click Cap Drug Cup, 12 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/THC, CLIA WAIVED
MERCEDES MEDICAL, LLC
MER MMDOAY6125
In Commercial Distribution

  • 10850011007720 ()
  • 00850011007723 ()
  • 00850011007570 ()
MER MMDOAY6125

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Platinum+ - 00850011007310

Platinum+ Click Cap Drug Cup, 12 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/THC, CLIA WAIVED
MERCEDES MEDICAL, LLC
MER HCDOAY6125
In Commercial Distribution

  • 00850011007334 ()
  • 00850011007327 ()
  • 00850011007310 ()
MER HCDOAY6125

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical

T2Bacteria® Cartridge Kit - M70890080710

The T2Bacteria Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Bacteria panel.
T2 BIOSYSTEMS, INC.
90-08071
In Commercial Distribution

  • M70890080710 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

OEC - 00618125190775

Kit, OEC MiniView C-Arm with 15cm FPD (Flat Panel Detector), Drape and Foot Switch Cover. Intended For Use With: OEC MiniView
TIDI PRODUCTS, LLC
31046
In Commercial Distribution

  • 10618125190789 ()
  • 00618125190775 ()
8849777

  • Medical equipment/instrument drape, single-use
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