SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8781 results)

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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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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
The T2Biothreat Panel components used to load the patient sample to be run and that contains disposables and Lysis Reagent
T2 BIOSYSTEMS, INC.
90-11400
In Commercial Distribution

  • M70890114000 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
90-01794
Not in Commercial Distribution

  • M70890017940 ()


  • Multiple Candida species nucleic acid IVD, reagent
CRL STAT10 panel Cup - KCUR920126 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/THC50(OX/SG/pH/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920126
In Commercial Distribution

  • 00817815021478 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 9 Panel Cup - KCUR920120 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25 (CR/NI/OX/PH/SG)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920120
In Commercial Distribution

  • 00817815021416 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 13 Panel Cup - KCUR920119 AMP1000/BAR 300/BUP10/BZO300/COC300/MAMP1000/MDMA500/MTD300/OPI2000/OXY100/PCP25/TCA1000/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920119
In Commercial Distribution

  • 00817815021386 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Cup-KCUR920115 AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50 (OX/SG/pH/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920115
In Commercial Distribution

  • 00817815021355 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920084
In Commercial Distribution

  • 00817815021140 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 9 panel Cup - KCUR920080 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920080
In Commercial Distribution

  • 00817815021058 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920084
In Commercial Distribution

  • 00817815020693 ()
  • 00817815020709 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
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
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 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
8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8CM5
Not in Commercial Distribution

  • 00816565020281 ()
IMCA-8CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8BB
Not in Commercial Distribution

  • 00816565020267 ()
IMCA-8BB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen 8 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+<COC>+<PPX>+(MET/OPI/PCP)+(BZO/MTD/BAR)
Instant Technologies, Inc.
DUE-187-311
In Commercial Distribution

  • 10817405024107 ()
  • 00817405024100 ()
DUE-187-311

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50
Instant Technologies, Inc.
ABTDOAW114701A
In Commercial Distribution

  • 30817405023876 ()
  • 00817405023875 ()
  • 10817405023872 ()
ABTDOAW114701A

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