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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Acuitas - 01812125010036

A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Opgen, Inc.
KT03U01-2
Not in Commercial Distribution

  • 01812125010036 ()
KT03U01-2

  • Nucleic acid amplification mastermix kit IVD

Acuitas - 20812125010031

A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Opgen, Inc.
KT03U01-2
Not in Commercial Distribution

  • 20812125010031 ()
KT03U01-2

  • Nucleic acid amplification mastermix kit IVD

Morpheus - 00852423006004

Morpheus® Control Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MOR0118
In Commercial Distribution

  • 00852423006004 ()
MOR0118

  • Ultrasound imaging system operator console
  • Radiology DICOM image processing application software
  • Urodynamic measurement system

BluRapids™ - 00850011007105

BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR CDOA2135
In Commercial Distribution

  • 00850011007105 ()
  • 10850011007102 ()
  • 20850011007109 ()
TNR CDOA2135

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • 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
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

BluRapids™ - 00850011007099

BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA
MERCEDES MEDICAL, LLC
TNR MMC12MOP
In Commercial Distribution

  • 00850011007099 ()
  • 10850011007096 ()
  • 20850011007093 ()
TNR MMC12MOP

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • 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
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical

Omega Medical Imaging, LLC - 00853901007025

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

U-Screen - 00858998006159

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/BZO)
Instant Tech Subsidiary Acquisition
USSCupA-6MB
Not in Commercial Distribution

  • 00858998006159 ()
USSCupA-6MB

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

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 - 00724995214357

The E-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214357 ()
LES14INNDT

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

HarmonyAIR - 00724995214340

The E-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214340 ()
LES14IN02T

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

HarmonyAIR - 00724995214333

The E-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214333 ()
LES14IN01T

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

HarmonyAIR - 00724995203115

HarmonyAIR A-Series High Density Single Adjustable Light 43-inch, Single Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203115 ()
LAH24A

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

HarmonyAIR - 00724995201111

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

  • 00724995201111 ()
LAS14NCNDT

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

HarmonyAIR - 00724995201104

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

  • 00724995201104 ()
LAS14NC02T

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

HarmonyAIR - 00724995201098

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

  • 00724995201098 ()
LAS14NC01T

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

HarmonyAIR - 00724995200909

A-Series High Definition Dual Light, Dual Flat Panel Monitor, No Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200909 ()
LAH14INND

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

HarmonyAIR - 00724995200893

A-Series High Definition Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200893 ()
LAH14IN02

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

HarmonyAIR - 00724995200886

A-Series High Definition Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200886 ()
LAH14IN01

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

HarmonyAIR - 00724995200848

A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, No Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200848 ()
LAS31NCND

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

HarmonyAIR - 00724995200831

A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 20-inch Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200831 ()
LAS31NC02

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

HarmonyAIR - 00724995200824

A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 13-inch Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200824 ()
LAS31NC01

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

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 - 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 - 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 - 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 - 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 - 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 - 00724995166526

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

  • 00724995166526 ()
LMH06N

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

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 - 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

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

iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup - 00817405024100

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

iScreen™ - 00817405023875

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

iScreen™ - 00817405023486

10 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, PCP25, THC50 SVT (CR,OX,SG)
Instant Technologies, Inc.
ABTDUAK110701A
In Commercial Distribution

  • 30817405023487 ()
  • 00817405023486 ()
  • 10817405023483 ()
ABTDUAK110701A

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

U-Screen - 00817405020973

U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR/SG/OX) 5 Panel Drug Screen (AMP500/BZO300/COC150/MET500/OPI300)
Instant Technologies, Inc.
USSCupA-5E
In Commercial Distribution

  • 00817405020973 ()


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

ImmuTest Drugs of Abuse Cup - 00816565020281

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

ImmuTest Drugs of Abuse Cup - 00816565020267

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

STATCUP® - 00816036026675

STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-21107-0-A
In Commercial Distribution

  • 00816036027177 ()
  • 00816036026675 ()
SCP-21107-0-A

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

STATCUP® - 00816036026651

STATCUP 8 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2387-0-A
In Commercial Distribution

  • 00816036027153 ()
  • 00816036026651 ()
SCP-2387-0-A

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