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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Schick AE Sensor Size 1 Ship Kit w/ 3ft Cable
SIRONA DENTAL, INC.
100007064
In Commercial Distribution

  • D7641000070641 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 1 Ship Kit w/ 9ft Cable
SIRONA DENTAL, INC.
100007063
In Commercial Distribution

  • D7641000070631 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 1 Ship Kit w/ 6ft Cable
SIRONA DENTAL, INC.
100007062
In Commercial Distribution

  • D7641000070621 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 2 RMA w/ 3ft Cable
SIRONA DENTAL, INC.
100007053
In Commercial Distribution

  • D7641000070531 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 2 RMA w/ 9ft Cable
SIRONA DENTAL, INC.
100007052
In Commercial Distribution

  • D7641000070521 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 2 RMA 45cm Cable
SIRONA DENTAL, INC.
100007050
In Commercial Distribution

  • D7641000070501 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 2 RMA w/ 6ft Cable
SIRONA DENTAL, INC.
100007049
In Commercial Distribution

  • D7641000070491 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 2 Ship Kit 45cm Cable
SIRONA DENTAL, INC.
100007037
In Commercial Distribution

  • D7641000070371 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 2 Ship Kit w/ 3ft Cable
SIRONA DENTAL, INC.
100007036
In Commercial Distribution

  • D7641000070361 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 2 Ship Kit w/ 9ft Cable
SIRONA DENTAL, INC.
100007035
In Commercial Distribution

  • D7641000070351 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor Size 2 Ship Kit w/ 6ft Cable
SIRONA DENTAL, INC.
100007020
In Commercial Distribution

  • D7641000070201 ()


  • Dental digital imaging sensor, intraoral
Intraoral Sensor Wallbox Without Display
SIRONA DENTAL, INC.
100006465
In Commercial Distribution

  • D7641000064651 ()


  • Dental digital imaging sensor, intraoral
Intraoral Sensor Wallbox Display Upgrade Kit
SIRONA DENTAL, INC.
100006457
In Commercial Distribution

  • D7641000064571 ()


  • Dental digital imaging sensor, intraoral
Intraoral Sensor Wallbox With Display
SIRONA DENTAL, INC.
100006451
In Commercial Distribution

  • D7641000064510 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor S0 Front Can Attach
SIRONA DENTAL, INC.
100006074
In Commercial Distribution

  • D7641000060740 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor S1 Front Can Attach
SIRONA DENTAL, INC.
100006040
In Commercial Distribution

  • D7641000060400 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor S2 Front Can Attach
SIRONA DENTAL, INC.
100006036
In Commercial Distribution

  • D7641000060360 ()


  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
EAGLE S
In Commercial Distribution

  • 07899581344701 ()
16000004525

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
EAGLE S
In Commercial Distribution

  • 07899581344695 ()
16000004524

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
D700 Slim
In Commercial Distribution

  • 07899581340727 ()
16000004374

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
D700 Slim
In Commercial Distribution

  • 07899581340697 ()
16000004373

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
Saevo Slim
In Commercial Distribution

  • 07899581340284 ()
16000004138

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
Saevo Slim
In Commercial Distribution

  • 07899581340277 ()
16000004137

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
Eagle S
In Commercial Distribution

  • 07899581340260 ()
16000004136

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
Eagle S
In Commercial Distribution

  • 07899581340253 ()
16000004135

  • Dental digital imaging sensor, intraoral
Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1 Ply Body, 2 Ply Front Pocket Panel, Misty, 21 3/4 x 44
STANDARD TEXTILE CO., INC.
95301682
In Commercial Distribution

  • 00634916000016 ()
  • 10634916000013 ()
95301682

  • Patient surgical drape, reusable
BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY,PCP,TCA,THC with 3 AD (+pH, OX,SG)
MERCEDES MEDICAL, LLC
TNR CDOA7125A3
In Commercial Distribution

  • 00850011007112 ()
  • 10850011007119 ()
  • 20850011007116 ()
TNR CDOA7125A3

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
The HarmonyAIR 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

  • 00724995172800 ()
LES02INND

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

  • 00724995172794 ()
LES02IN02

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

  • 00724995172787 ()
LES02IN01

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