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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iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Screen for AMP1000, COC300, MET1000, OPI2000, THC50
Instant Technologies, Inc.
I-DXP-5M
In Commercial Distribution

  • 00817405021079 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Screen for AMP1000, COC300, OPI2000, PCP25, THC50
Instant Technologies, Inc.
I-DXP-5A
In Commercial Distribution

  • 00817405021055 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for(AMP/BZO/BUP/COC/OPI300/OXY/THC)
Instant Technologies, Inc.
I-DXP-177-01
In Commercial Distribution

  • 00817405020287 ()
I-DXP-177-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel CLIA Waived Click Cup w/ SVT AMP500, BAR300, BUP10, BZO300, COC150, MDMA500, MET500, MOP300, MTD300, OXY100, PCP25, THC50 w/ SVT OX/SG/pH
Instant Technologies, Inc.
ABTDUAW112706F
In Commercial Distribution

  • 30817405023838 ()
  • 00817405023837 ()
  • 10817405023834 ()
ABTDUAW112706F

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel CLIA Waived Flat Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, THC50 w/ SVT CR/SG/Ph
Instant Technologies, Inc.
ABTDUAW112705E
In Commercial Distribution

  • 30817405023814 ()
  • 00817405023813 ()
  • 10817405023810 ()
ABTDUAW112705E

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 14 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/PPX/TCA/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-13147-0-A
In Commercial Distribution

  • 00816036025159 ()
  • 00816036025319 ()
STATⅡ-13147-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP1000)+BUP with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-13M
Not in Commercial Distribution

  • 00816565020304 ()
IMCA-13M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
X-MIND trium PAN CBCT including one removable pan sensor and a CBCT sensor, with control panel on the left and ceph arm on the left
DE GÖTZEN SRL
XMT PAN 3D L CEPH L
Not in Commercial Distribution

  • D804W09002330 ()
W0900233

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT including one removable pan sensor and a CBCT sensor, with control panel on the left and ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D L CEPH R
Not in Commercial Distribution

  • D804W09000120 ()
W0900012

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50 3mm Strip - 25 Pack Box.
MEDICAL DISTRIBUTION GROUP INC
ID-H13-1
Not in Commercial Distribution

  • 01085072100710 ()
  • 00850721007105 ()
ID-H13-1

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
175785
In Commercial Distribution

  • 10768455102591 ()
  • 00768455102594 ()
  • 00768455181315 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
175779
In Commercial Distribution

  • 10768455102539 ()
  • 00768455102532 ()
  • 00768455181254 ()


  • One-piece intestinal ostomy bag, open-ended
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The HarmonyAIR Dual Light with Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172862 ()
LES02INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172848 ()
LES02IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172855 ()
LES02IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light 35-inchwith Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173586 ()
LES04INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inch 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

  • 00724995173289 ()
LES24INND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light 43-inch 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

  • 00724995173265 ()
LES24IN01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light 35-inch 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

  • 00724995173524 ()
LES04INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inch 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

  • 00724995173517 ()
LES04IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inch 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

  • 00724995173500 ()
LES04IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173333 ()
LES24IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual 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

  • 00724995175924 ()
LES56INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual 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

  • 00724995175917 ()
LES56IN02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual 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

  • 00724995175900 ()
LES56IN01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175863 ()
LES13INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175856 ()
LES13IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175849 ()
LES13IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175627 ()
LES11INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175610 ()
LES11IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175603 ()
LES11IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605201
In Commercial Distribution

  • 00690286000490 ()
  • 10690286000497 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Amphetamine, and Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605101
In Commercial Distribution

  • 10690286000428 ()
  • 00690286000421 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Amphetamine, Cocaine, Methamphetamine, Opiates, Phencyclidine, and THC (cannabinoids) drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
600715
Not in Commercial Distribution

  • 00690286000391 ()
  • 10690286000398 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Barbiturates and Benzodiazepines and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601660
In Commercial Distribution

  • 00690286000353 ()
  • 10690286000350 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Barbiturates, and Benzodiazepines drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601607
In Commercial Distribution

  • 00690286000339 ()
  • 10690286000336 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Cocaine, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601645
Not in Commercial Distribution

  • 10690286000251 ()
  • 00690286000254 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601639
Not in Commercial Distribution

  • 10690286000220 ()
  • 00690286000223 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Barbiturates, and Benzodiazepines drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601622
In Commercial Distribution

  • 10690286000176 ()
  • 00690286000179 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepines, and Barbiturates drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604020
In Commercial Distribution

  • 10690286000039 ()
  • 00690286000032 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
  • Multiplex analyser IVD, laboratory
"Keypoint Focus Notebook System, FRA Including: - Notebook PC with Keypoint software, MS Office - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071102
Not in Commercial Distribution

  • 05704736017138 ()


  • Electromyograph
"Keypoint Focus Notebook System, Intl. 230V ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071101
Not in Commercial Distribution

  • 05704736017121 ()


  • Electromyograph
"Keypoint Focus Notebook System, Intl. 115V ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A0711HA
Not in Commercial Distribution

  • 05704736017114 ()


  • Electromyograph
SELECT TL4 toilet bracket, for wall outlet, prepared for shower toilet seat, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9144
In Commercial Distribution

  • 05708590372938 ()
R9144000

  • Height-adjustable toilet bracket, electric
SELECT TL4 toilet bracket, for wall outlet, prepared for shower toilet seat, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9144
In Commercial Distribution

  • 05708590372921 ()
R9144112

  • Height-adjustable toilet bracket, electric
SELECT TL4 toilet bracket, for floor outlet, prepared for shower toilet seat, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9134
In Commercial Distribution

  • 05708590372853 ()
R9134000

  • Height-adjustable toilet bracket, electric
SELECT TL4 toilet bracket, for floor outlet, prepared for shower toilet seat, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9134
In Commercial Distribution

  • 05708590372846 ()
R9134112

  • Height-adjustable toilet bracket, electric
U-Screen Squared Integrated Cup with Adulterants(CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-12BUP300
Not in Commercial Distribution

  • 00858998006104 ()
USSCupA-12BUP300

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