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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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InfiMed i5, DSA, CCD Camera - 00858086006009

No Description
INFIMED, INC.
i5 DSA
Not in Commercial Distribution

  • 00858086006009 ()


  • X-ray system computer, diagnostic, general-purpose

ID NOW RSV Control Swab Kit - 10811877010538

Control Swabs intended for use only with the ID NOW RSV product.
Alere Scarborough, Inc.
435-080
In Commercial Distribution

  • 10811877010538 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, control

ID NOW RSV - 10811877010521

A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
In Commercial Distribution

  • 10811877010521 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Alere i RSV Control Swab Kit - 10811877010132

Control Swabs intended for use only with the Alere i RSV product.
Alere Scarborough, Inc.
435-080
Not in Commercial Distribution

  • 10811877010132 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, control

Alere i RSV - 10811877010118

A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
Not in Commercial Distribution

  • 10811877010118 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Panther Fusion® - 15420045509320

Panther Fusion® AdV/hMPV/RV Controls Kit.
Hologic, Inc.
AMR CTRLS, PANTHER FUSION, IVD
In Commercial Distribution

  • 15420045509320 ()
PRD-04338

  • Multiple-genus respiratory virus nucleic acid IVD, control

Panther Fusion® - 15420045509290

The Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV).
Hologic, Inc.
AMR KIT, PANTHER FUSION, 96T, IVD
In Commercial Distribution

  • 15420045509290 ()
PRD-04330

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Rapid Response - 00722066004784

10 Panel One Step DOA Cup (10.11) - COC(300) AMP(1000) MET(1000) THC(50) EDDP(300) MOP(300) OPI(2000) OXY(100) BZO(300) BUP(10)
BTNX Inc
D10.11-1V
In Commercial Distribution

  • 00722066004784 ()


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

HarmonyAIR - 00724995172831

The HarmonyAIR Dual Light with Single Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172831 ()
LES02NCND

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

HarmonyAIR - 00724995172824

The HarmonyAIR Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172824 ()
LES02NC02

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

HarmonyAIR - 00724995172817

The HarmonyAIR Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172817 ()
LES02NC01

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

HarmonyAIR - 00724995173562

The HarmonyAIR Single Light 35-inch 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

  • 00724995173562 ()
LES04IN01T

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

HarmonyAIR - 00724995173319

The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173319 ()
LES24NCND

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

HarmonyAIR - 00724995173302

The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173302 ()
LES24NC02

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

HarmonyAIR - 00724995173579

The HarmonyAIR Single Light 35-inch 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

  • 00724995173579 ()
LES04IN02T

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

HarmonyAIR - 00724995173548

The HarmonyAIR Single Light 35-inchwith Single Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173548 ()
LES04NC02

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

HarmonyAIR - 00724995173531

The HarmonyAIR Single Light 35-inchwith Single Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173531 ()
LES04NC01

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

HarmonyAIR - 00724995173401

The HarmonyAIR Single High Definition Light 35-inchwith 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

  • 00724995173401 ()
LEH04INND

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

HarmonyAIR - 00724995173340

The HarmonyAIR Single Light 43-inch 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

  • 00724995173340 ()
LES24INNDT

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

HarmonyAIR - 00724995173326

The HarmonyAIR Single Light 43-inch 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

  • 00724995173326 ()
LES24IN01T

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

HarmonyAIR - 00724995175986

The HarmonyAIR Hybrid 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

  • 00724995175986 ()
LES56INNDT

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

HarmonyAIR - 00724995175979

The HarmonyAIR Hybrid 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

  • 00724995175979 ()
LES56IN02T

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

HarmonyAIR - 00724995175962

The HarmonyAIR Hybrid 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

  • 00724995175962 ()
LES56IN01T

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

HarmonyAIR - 00724995175832

The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175832 ()
LES13NCND

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

HarmonyAIR - 00724995175825

The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175825 ()
LES13NC02

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

HarmonyAIR - 00724995175818

The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175818 ()
LES13NC01

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

HarmonyAIR - 00724995175597

The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175597 ()
LES11NCND

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

HarmonyAIR - 00724995175580

The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175580 ()
LES11NC02

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

HarmonyAIR - 00724995175573

The HarmonyAIR Single Light with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175573 ()
LES11NC01

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

EZ-SCREEN® CUP - 00690286000506

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605202
In Commercial Distribution

  • 00690286000506 ()
  • 10690286000503 ()


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

EZ-SCREEN® CUP - 00690286000445

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Amphetamine, Benzodiazepines, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605103
In Commercial Distribution

  • 10690286000442 ()
  • 00690286000445 ()


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

SURE-SCREEN® - 00690286000384

A qualitative one-step immunochromatographic test panel for the detection of Amphetamine, Benzodiazepines, Cocaine, Methamphetamine, Opiates, Oxycodone, and THC (Cannabinoids) drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
600686
Not in Commercial Distribution

  • 10690286000381 ()
  • 00690286000384 ()


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

Bicycle Health - 10850013035202

Bicycle Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (NI/CR) Approx. 3mm Strip 25 Tests/Box
MEDICAL DISTRIBUTION GROUP INC
ID-BH9-ADULT-1-AZ25
In Commercial Distribution

  • 00850013035205 ()
  • 10850013035202 ()
ID-BH9-ADULT-1-AZ25

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

Identify Health - 10850013035196

Identify Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (NI/CR) Approx. 3mm Strip 25 Tests/Box
MEDICAL DISTRIBUTION GROUP INC
ID-H9-ADULT-1-AZ25
In Commercial Distribution

  • 00850013035199 ()
  • 10850013035196 ()
ID-H9-ADULT-1-AZ25

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

iCup® - 10817405021335

iCup® E&I Urine Test 11 Panel Drug Screen Cup w/SVT (CR/pH/SG) (AMP1000/BAR300/BZO300/BUP10/COC300/MTD300/MET1000/MDMA500/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
DPG-1117-141
In Commercial Distribution

  • 00817405021338 ()
  • 10817405021335 ()
DPG-1117-141

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

Rapid Response - 10722066005641

12- Drug Test Panel - 25/kit (12.36) - AMP1000 BAR300 BZO300 COC300 MDMA500 MET1000 OPI2000 PCP25 THC50 MTD300 OXY100 PPX300. For the detection of drugs in human urine.
BTNX Inc
D12.36-1P29-25
In Commercial Distribution

  • 00722066005644 ()
  • 10722066005641 ()


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

iScreen™ - 00817405023882

14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, OXY100, PCP25, PPX300, TCA1000, THC50 w/ SVT OX/SG/pH
Instant Technologies, Inc.
ABTDUAW114704D
In Commercial Distribution

  • 30817405023883 ()
  • 00817405023882 ()
  • 10817405023889 ()
ABTDUAW114704D

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

iScreen™ - 00817405023844

14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50 w/ SVT OX/SG/Ph
Instant Technologies, Inc.
ABTDUAW114703C
In Commercial Distribution

  • 30817405023845 ()
  • 00817405023844 ()
  • 10817405023841 ()
ABTDUAW114703C

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

STATCUP® II - 00816036020949

STATCUP II, 12 Panel CLIA WAIVED Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC + ph,CR,OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-71127-A-CR
In Commercial Distribution

  • 00816036020949 ()
  • 00816036021151 ()
STATII-71127-A-CR

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

STATCUP® II - 00816036025340

STATCUP II 12 Panel CLIA Waived Test Cup W/AD, AMP/BARB/BZO/BUP/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-43147-0-A
In Commercial Distribution

  • 00816036025340 ()
  • 00816036025357 ()
STATII-43147-0-A

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

STATCUP® II - 00816036020987

STATCUP II, 12 Panel CLIA WAIVED Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC + ph,SG,OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-71127-A
In Commercial Distribution

  • 00816036020987 ()
  • 00816036021199 ()
STATII-71127-A

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

X-MIND trium - D804W09002400

X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the right and ceph arm on the left configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN L CEPH R 3D READY
Not in Commercial Distribution

  • D804W09002400 ()
W0900240

  • Stationary panoramic/tomographic dental x-ray system, digital

X-MIND trium - D804W09002390

X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the left and ceph arm on the right configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN R CEPH L 3D READY
Not in Commercial Distribution

  • D804W09002390 ()
W0900239

  • Stationary panoramic/tomographic dental x-ray system, digital

X-MIND trium - D804W09002310

X-MIND trium PAN CBCT CEPH version including one PAN sensor,with control panel on the right side including one removable ceph sensor ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D R CEPH R
Not in Commercial Distribution

  • D804W09002310 ()
W0900231

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital

X-MIND trium - D804W09000060

X-MIND trium PAN CBCT CEPH version including one PAN sensor, with control panel on the right side including one removable ceph sensor ceph arm on the left
DE GÖTZEN SRL
XMT PAN 3D R CEPH L
Not in Commercial Distribution

  • D804W09000060 ()
W0900006

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital

ESTEEM+ - 00768455111893

Esteem®+ One-Piece Drainable Cut-To-Fit Pouch W/ Invisiclose®, Filter, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 2 2/5" By 2 3/4" (60/70Mm)
CONVATEC, PURCHASING DEPARTMENT
416719
In Commercial Distribution

  • 10768455111890 ()
  • 00768455111893 ()
  • 00768455188345 ()


  • One-piece intestinal ostomy bag, open-ended

ESTEEM+ - 00768455111886

Esteem®+ One-Piece Drainable Cut-To-Fit Pouch W/ Invisiclose®, Filter, Modified Stomahesive®, One-Sided Comfort Panel 12" Transparent, 2 2/5" By 2 3/4" (60/70Mm)
CONVATEC, PURCHASING DEPARTMENT
416718
In Commercial Distribution

  • 10768455111883 ()
  • 00768455111886 ()
  • 00768455188338 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455102587

Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1 3/4" (45 Mm.
CONVATEC, PURCHASING DEPARTMENT
175784
In Commercial Distribution

  • 10768455102584 ()
  • 00768455102587 ()
  • 00768455181308 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455102570

Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1 1/2" (38 Mm.
CONVATEC, PURCHASING DEPARTMENT
175783
In Commercial Distribution

  • 10768455102577 ()
  • 00768455102570 ()
  • 00768455181292 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455102563

Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1 3/8" (35 Mm.
CONVATEC, PURCHASING DEPARTMENT
175782
In Commercial Distribution

  • 10768455102560 ()
  • 00768455102563 ()
  • 00768455181285 ()


  • One-piece intestinal ostomy bag, open-ended
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