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 HarmonyAIR E-Series Dual Light, Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168360 ()
LES02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series DL LT , Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168353 ()
LEH02

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The Single High Density M5, No 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

  • 00724995166588 ()
LMH24N

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The G5 Single Light Camera with ConnectPoint Express, Single Flat Panel Monitor and Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995167370 ()
P056939299

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The G5 Dual Light with Camera, 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

  • 00724995167158 ()
LGH12NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Single M5 without Control with Single Flat Panel Monitor, Spring Arm and Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165680 ()
LM24NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Single M5 without Control with Single M5 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

  • 00724995165659 ()
LM04NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
SMC PRIVATE LABEL Multi-Panel Drug Test Cup, 6 Panel, CLIA Waived, Click Seal Cap, AMP, BZO, COC, mAMP, OPI, THC, 25/BX
TRANSMED CO, LLC
REF-EWCUP-264
In Commercial Distribution

  • 00850798007749 ()
  • 00850798007732 ()
  • 00850798007725 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
"Keypoint Focus Module: CN Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701CN
Not in Commercial Distribution

  • 05704736019477 ()


  • Electromyograph
(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI2000+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card
Lifesign L.L.C.
11125AA2K
In Commercial Distribution

  • 00868348000218 ()
11125AA2K

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MET1000+OPI2000+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup
Lifesign L.L.C.
71125AA2K
In Commercial Distribution

  • 00868348000232 ()
71125AA2K

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MET1000+OPI300+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup
Lifesign L.L.C.
71125AA
In Commercial Distribution

  • 00868348000225 ()
71125AA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card
Lifesign L.L.C.
11125AA
In Commercial Distribution

  • 00868348000201 ()
11125AA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The E-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214388 ()
LES14NCNDT

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The E-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214371 ()
LES14NC02T

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
The E-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214364 ()
LES14NC01T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The E-Series High Density 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

  • 00724995214234 ()
LEH14INNDT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The E-Series High Density 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

  • 00724995214227 ()
LEH14IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The E-Series High Density 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

  • 00724995214210 ()
LEH14IN01T

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
The E-Series Dual Flat Panel Monitor Arm, 51-inch Arm, No Drop Tube, No Camera is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995214111 ()
LES31NCND

  • Medical monitor/light mount
The E-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 20-inch Drop Tube, No Camera is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995214104 ()
LES31NC02

  • Medical monitor/light mount
The E-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 13-inch Drop Tube, No Camera is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995214098 ()
LES31NC01

  • Medical monitor/light mount
A-Series High Definition 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

  • 00724995200992 ()
LAH14NCNDT

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
A-Series High Definition 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

  • 00724995200985 ()
LAH14NC02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
A-Series High Definition 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

  • 00724995200978 ()
LAH14NC01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
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
Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
Opgen, Inc.
CP3402
Not in Commercial Distribution

  • 10812125010058 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
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
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 PAN T version including one removable pan sensor with control panel on the right configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN 3D READY R
Not in Commercial Distribution

  • D804W09002250 ()
W0900225

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
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
X-MIND trium PAN CEPH version including one removable ceph sensor, with control panel on the right and ceph arm on the left
DE GÖTZEN SRL
XMT PAN R CEPH L
Not in Commercial Distribution

  • D804W09000030 ()
W0900003

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
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
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
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
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® 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
Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.64-2FC1E)- AMP50, COC20, MET50, OPI40, OXY20, PCP10. For employment and insurance testing.
BTNX Inc
D6.64-2FC1E
In Commercial Distribution

  • 00722066006801 ()
  • 10722066006808 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.61-2FC1E)- AMP50, COC20, BAR50, OPI40, PCP10, THC40. For employment and insurance testing.
BTNX Inc
D6.61-2FC1E
In Commercial Distribution

  • 00722066006795 ()
  • 10722066006792 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.3.1-2FC1E)- AMP50, COC20, MET50, OPI40, PCP10, THC40. For employment and insurance testing.
BTNX Inc
D6.3.1-2FC1E
In Commercial Distribution

  • 00722066006788 ()
  • 10722066006785 ()


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