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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CLIAwaived,Inc. One Step Drug Test Cup-7 panel configuration (THC,COC,OPI 300,mAMP,MTD,OXY, BZO) -(25T/KIT)
Cliawaived, Inc.
CLIA-IDTC-7-60717
In Commercial Distribution

  • 00816610020921 ()
CLIA-IDTC-7-60717

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCupA-5M
In Commercial Distribution

USSCupA-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Cup - KCUR920110 BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI300/OXY100/PCP25/THC50 (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920110
In Commercial Distribution

  • 00817815021324 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 8 Panel Dip - KCUR920121 AMP1000/BAR300/BZO300/COC300/MET1000/OPI2000/PCP25/THC50 (CR/NI/OX/PH/SG)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920121
In Commercial Distribution

  • 00817815020907 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Fastep 10 Panel Urine Drug Test Cup (AMP, BUP, BZO, COC, MET, MDMA,MOP,MTD,OXY,THC) – 4 pack
Azure Biotech, Inc.
AZC-8105
In Commercial Distribution

  • 00810022630402 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DUA-167-012 (Ox/SG/pH)+(mAMP/OPI/PCP)+(AMP/COC/THC)MULTI-DRUG 6 PANEL INTEGRATED CUP WITH previous (GTIN 10869419000202)
Quest Diagnostics
UDOA-6CA-0503-01
In Commercial Distribution

  • 00869419000205 ()
  • 20869419000209 ()
DUA-167-012-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1" (25Mm)
CONVATEC, PURCHASING DEPARTMENT
416743
In Commercial Distribution

  • 10768455112132 ()
  • 00768455112135 ()
  • 00768455188529 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1" (25Mm)
CONVATEC, PURCHASING DEPARTMENT
416742
In Commercial Distribution

  • 10768455112125 ()
  • 00768455112128 ()
  • 00768455188512 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1" (25Mm)
CONVATEC, PURCHASING DEPARTMENT
416725
In Commercial Distribution

  • 10768455111951 ()
  • 00768455111954 ()
  • 00768455188383 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Transparent, 1" (25Mm)
CONVATEC, PURCHASING DEPARTMENT
416724
In Commercial Distribution

  • 10768455111944 ()
  • 00768455111947 ()
  • 00768455188376 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Cut-To-Fit Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Trans
CONVATEC, PURCHASING DEPARTMENT
125330
In Commercial Distribution

  • 10768455101914 ()
  • 00768455101917 ()
  • 00768455180455 ()


  • One-piece intestinal ostomy bag, open-ended
Identify Health 4 Panel Drug Test Dip- CLIA Waived AMP500, COC150, MOP300, PCP25 Approx. 3.0mm strip 25 Tests/Box
MEDICAL DISTRIBUTION GROUP INC
ID-H4-DIP-1-AZ25
In Commercial Distribution

  • 00850013035304 ()
  • 10850013035301 ()
ID-H4-DIP-1-AZ25

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