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

Show Filters

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
One Step 12 Panel DOA Cup (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25 pH/CRE/SG.
BTNX Inc
D12.5.1-1VA
In Commercial Distribution

  • 00722066005675 ()
  • 10722066005672 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 11 Panel Cup- KCUR920082 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920082
In Commercial Distribution

  • 00817815020877 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
T-Cup® Multi-Drug Urine Test Cup with Adulterants (CR, NI, pH, OX, SG) 7 panel AMP1000, COC300, MET500, OPI300, OXY100, PCP25, THC50
Instant Technologies, Inc.
TDOA-7A
In Commercial Distribution

  • 00817405021086 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen 10 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+<MDMA>+<OXY>+(AMP/COC)+(MET/MOP/PCP)+(BZO/MTD/BAR)
Instant Technologies, Inc.
DUE-1107-541
In Commercial Distribution

  • 10817405024084 ()
  • 00817405024087 ()
DUE-1107-541

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 PANEL CLIA WAIVED ROUND CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50 + CR, pH, S.G.
Instant Technologies, Inc.
ABTDUAW113701A
In Commercial Distribution

  • 10817405023308 ()
  • 00817405023301 ()
  • 30817405023302 ()
ABTDUAW113701A

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

  • 00812125010051 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
12 panel Urine Drug Screen Cup, AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50, Adulterants (OX/SG/pH).
HENRY SCHEIN, INC.
5703927
In Commercial Distribution

  • 00304040186732 ()
  • 10304040186739 ()
5703927

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II, 12 Panel CLIA WAIVED Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-71127
In Commercial Distribution

  • 00816036020932 ()
  • 00816036021144 ()
STATII-71127

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MOP/MTD/OXY/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-41107-0-A
In Commercial Distribution

  • 00816036026576 ()
  • 00816036027078 ()
SCP-41107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC + CR,OX,pH, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-31107-0-A
In Commercial Distribution

  • 00816036026569 ()
  • 00816036027061 ()
SCP-31107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 panel test cup, (BZO/BAR)+(OXY/MDMA)+(PCP/AMP)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-10M5
Not in Commercial Distribution

  • 00816565020359 ()
IMCA-10M5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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 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 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 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
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
DUA-1107-061 (Ox/SG/pH)+(mAMP/OPI/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)+<PPX> 5 MULTI-DRUG 10 PANEL UDOA-12CE-0712-01 (Previous GTIN 10869419000219)
Quest Diagnostics
UDOA-10CA-0503-01
In Commercial Distribution

  • 00869419000212 ()
  • 20869419000230 ()
DUA-1107-061-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Esteem®+ One-Piece Drainable Cut-To-Fit, Clipped, Modified Stomahesive® With Filter, 1 Comfort Panel,Standard 12", Transparent 13/16-2 3/4", 20-70Mm
CONVATEC, PURCHASING DEPARTMENT
421848
In Commercial Distribution

  • 10768455153166 ()
  • 00768455153169 ()
  • 00768455172580 ()


  • One-piece intestinal ostomy bag, closed-ended
Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap, W/1 Sided Comfort Panel, Trans, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
650830
In Commercial Distribution

  • 10768455106636 ()
  • 00768455106639 ()
  • 00768455190249 ()


  • One-piece intestinal ostomy bag, open-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Opaque, 1 3/4 in (45 mm)
CONVATEC, PURCHASING DEPARTMENT
175772
Not in Commercial Distribution

  • 10768455102492 ()
  • 00768455102495 ()
  • 80768455102491 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Opaque, 1 1/2 in (38 mm)
CONVATEC, PURCHASING DEPARTMENT
175771
Not in Commercial Distribution

  • 10768455102485 ()
  • 00768455102488 ()
  • 80768455102484 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter. with One Sided Comfort Panel, Opaque, 1 1/4 in (32 mm)
CONVATEC, PURCHASING DEPARTMENT
175770
Not in Commercial Distribution

  • 10768455102478 ()
  • 00768455102471 ()
  • 80768455102477 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 1 3/4 in (45 mm)
CONVATEC, PURCHASING DEPARTMENT
175765
Not in Commercial Distribution

  • 10768455102416 ()
  • 00768455102419 ()
  • 80768455102415 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 1 1/2 in (38 mm)
CONVATEC, PURCHASING DEPARTMENT
175764
Not in Commercial Distribution

  • 10768455102409 ()
  • 00768455102402 ()
  • 80768455102408 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 1 1/4 in (32 mm)
CONVATEC, PURCHASING DEPARTMENT
175763
Not in Commercial Distribution

  • 10768455102393 ()
  • 00768455102396 ()
  • 80768455102392 ()


  • One-piece intestinal ostomy bag, closed-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 3/4" (19Mm.)
CONVATEC, PURCHASING DEPARTMENT
125338
In Commercial Distribution

  • 10768455101990 ()
  • 00768455101993 ()
  • 00768455180523 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 3/4" (19Mm.)
CONVATEC, PURCHASING DEPARTMENT
125331
In Commercial Distribution

  • 10768455101921 ()
  • 00768455101924 ()
  • 00768455180462 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Trans, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022769
In Commercial Distribution

  • 10768455101594 ()
  • 00768455101597 ()
  • 00768455179237 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Trans, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022765
In Commercial Distribution

  • 10768455101556 ()
  • 00768455101559 ()
  • 00768455179190 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Opaque, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022762
In Commercial Distribution

  • 10768455101525 ()
  • 00768455101528 ()
  • 00768455179169 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022758
In Commercial Distribution

  • 10768455101488 ()
  • 00768455101481 ()
  • 00768455179121 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 10" Opaque, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022755
In Commercial Distribution

  • 10768455101457 ()
  • 00768455101450 ()
  • 00768455179091 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 10" Opaque, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022751
In Commercial Distribution

  • 10768455101419 ()
  • 00768455101412 ()
  • 00768455179053 ()


  • One-piece intestinal ostomy bag, open-ended
HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution

  • B440HVCP030 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
HeartVista Cardiac Package
Heartvista, Inc.
020301
In Commercial Distribution

  • B440HVCP020 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
ResolutionMD® Web is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD Inc.
RMD-WEB-I
Not in Commercial Distribution

  • B037RESMDWEB0 ()


  • Radiological PACS software
ResolutionMD® Mobile is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant medical images as well as reports on the mobile device.
ResolutionMD Inc.
RMD-MOB-I
Not in Commercial Distribution

  • B037RESMDMOB0 ()


  • Radiological PACS software
Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, 2XL
STANDARD TEXTILE CO., INC.
75674913
In Commercial Distribution

  • 10634916797173 ()
  • 00634916797176 ()


  • Surgical gown, reusable
Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, X-Large
STANDARD TEXTILE CO., INC.
75674914
In Commercial Distribution

  • 10634916797166 ()
  • 00634916797169 ()


  • Surgical gown, reusable
Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Large
STANDARD TEXTILE CO., INC.
75674915
In Commercial Distribution

  • 10634916797159 ()
  • 00634916797152 ()


  • Surgical gown, reusable
BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/OPI2000/OXY/PCP/THC ; Adulterants: +pH, OX,SG
MERCEDES MEDICAL, LLC
TNR CDOA5125A3
In Commercial Distribution

  • 00850011007075 ()
  • 10850011007072 ()
  • 20850011007079 ()
TNR CDOA5125A3

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • 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
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panel (Amphetamine, Barbiturate, Buprenorphine, Benzodiazepine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D12.2-1P29-25
In Commercial Distribution

  • 00722066003688 ()
  • 00722066004074 ()
D12.2-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR E-Series Dual Flat Panel Monitor ARM, 67-inch ARM 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

  • 00724995168674 ()
LES57

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

  • 00724995168650 ()
LES56

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

  • 00724995168421 ()
LES04

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Dual Spindle Light Head with Video 1750mm Single Flat Panel Monitor 1600mm G-Series 11008906 is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
In Commercial Distribution

  • 00724995170479 ()
LK00015

  • Medical monitor/light mount
The HarmonyAIR E-Series Single Light 43-inch, 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

  • 00724995168407 ()
LES24

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
< 1 ... 154 155 156 157 158 ... 187 >