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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Electric Motor with cable 1.8m
W & H Dentalwerk Bürmoos GmbH
30281000
In Commercial Distribution

  • J021302810000 ()
  • J021302810001 ()


  • Dental surgical power tool motor, electric
  • Dental delivery system instrument unit, electric
QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Curetis GmbH
QIAGEN® EZ1® Advanced XL System
Not in Commercial Distribution

62005

  • Specimen processing instrument IVD
5 Multi Drug Test Panel ( AMP1000 • COC 300 • OPI2000 •THC 50 • PCP25)
IDUN SOLUTIONS LLC
21505040010308-C
In Commercial Distribution

  • 00857275007568 ()
  • 00857275007483 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Single Drug Urine Test Panel, Fentanly, Employment And Insurance Testing, Exempt: FTY.
Instant Technologies, Inc.
ATS-FEN
In Commercial Distribution

  • 00858945006959 ()
ATS-FEN

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
Single Drug Urine Test Panel, Opiates, Employment and Insurance Testing, Exempt: TRA.
Instant Technologies, Inc.
ATS-TRAM
In Commercial Distribution

  • 00858945006935 ()
ATS-TRAM

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Card (THC50/COC300/OPI2000/AMP1000/MET1000)
Medical Disposables Corp
MDC-254R
In Commercial Distribution

  • 00860003196908 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 14 Panel Drug Test Card (THC50/COC300/OPI2000/AMP1000/MET1000)
Medical Disposables Corp
MDC-254R
In Commercial Distribution

  • 00860003196984 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Cup (THC50/COC300/OPI2000/AMP1000/MET1000)
Medical Disposables Corp
MDC-254R
In Commercial Distribution

  • 00860001731996 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step 5 Panel DOA Cup (5.75) - COC300 MET1000 AMP1000 OPI2000 OXY100
BTNX Inc
D5.75-1V
In Commercial Distribution

  • 00722066005095 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step 5 Panel DOA Cup (5.1.1) - COC150 AMP500 MET500 THC50 MOP2000
BTNX Inc
D5.1.1-1V
In Commercial Distribution

  • 00722066004883 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step 5 Panel DOA Cup (5.2) - COC300 AMP1000 THC50 OPI2000 PCP25
BTNX Inc
D5.2-1V
In Commercial Distribution

  • 00722066004647 ()
  • 00722066004739 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Panel Left-hand Shoulder Chair Pad is used on the Shoulder Chair.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171599 ()
BF444

  • Operating table mattress, basic
The Panel Right-hand Shoulder Chair Pad is used on the Shoulder Chair.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171582 ()
BF443

  • Operating table mattress, basic
Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)
WIDE corporation
MX50YQS
In Commercial Distribution

  • 08809241513087 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)
WIDE corporation
CX50YQS
In Commercial Distribution

  • 08809241513070 ()


  • Image display unit, colour
QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC043
Not in Commercial Distribution

  • 01812125010074 ()
AC043

  • Specimen processing instrument IVD
Healgen (DrugConfirm) - 6 Panel Dip Test: BZO300/COC300/mAMP1000/MOP2000/OXY100/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-564
In Commercial Distribution

  • 00895330002967 ()


  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Healgen (DrugConfirm) - 6 Panel Dip Card, CLIA AMP1000/BZO300/COC300/mAMP1000/MOP2000
CONFIRM BIOSCIENCES, INC.
CB-HE-264
In Commercial Distribution

  • 00895330002813 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
PANEL 10 COC/THC/OPI300/AMP/MAMP/BZO/BAR/OXY/MTD/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020182
In Commercial Distribution

  • 10858904006393 ()
  • 00858904006396 ()
DOA-1104-531

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 10 COC/AMP/M-AMP/THC/MTD/OPI/PCP/BAR/BZO/TCA
REDWOOD TOXICOLOGY LABORATORY, INC.
011020025
In Commercial Distribution

  • 10858904006294 ()
  • 00858904006297 ()
DOA-2104-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 10 COC/M-AMP/THC/MTD/MDMA/OPI/OXY/PCP/BAR/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020138
In Commercial Distribution

  • 10858904006478 ()
  • 00858904006471 ()
DOA-1104-401

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC/THC/OPI/AMP/MAMP/BARBZO/MTD/OXY/PCP/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020185
In Commercial Distribution

  • 10858904006423 ()
  • 00858904006426 ()
DOA-1114-111

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ25
In Commercial Distribution

  • 20850721007710 ()
  • 10850721007713 ()
  • 00850721007716 ()
ID-THC-DIP-AZ25

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ15
In Commercial Distribution

  • 20850721007475 ()
  • 10850721007478 ()
  • 00850721007471 ()
ID-THC-DIP-AZ15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ5
In Commercial Distribution

  • 20850721007468 ()
  • 10850721007461 ()
  • 00850721007464 ()
ID-THC-DIP-AZ5

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
6 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-664-RCN
In Commercial Distribution

  • 20850721007116 ()
  • 10850721007119 ()
  • 00850721007112 ()
U-CUP-664-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Screening Test Cup BZO/COC/OPI300/MTD/OXY/BUP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-964-RCN
In Commercial Distribution

  • 20850721007048 ()
  • 10850721007041 ()
  • 00850721007044 ()
U-CUP-964-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ15
In Commercial Distribution

  • 20850721007871 ()
  • 10850721007874 ()
  • 00850721007877 ()
ID-THC-DIP-AZ15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ10
In Commercial Distribution

  • 20850721007598 ()
  • 10850721007591 ()
  • 00850721007594 ()
ID-THC-DIP-AZ10

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
90cm single pivot 7 panel under table shield low profile RIGHT HAND
AADCO MEDICAL, INC.
S-315R
In Commercial Distribution

  • 00840348508789 ()
S-315R

  • Radiation shielding table drape
UNDER-TBL MTD RAD SHIELD 70CM H X 90CM W WITH TOP PANEL
AADCO MEDICAL, INC.
S-314A
In Commercial Distribution

  • 00840348508734 ()
S-314A

  • Radiation shielding table drape
6 Panel Drug Screening Test Cup BZO/COC/MET/OPI300/OXY/AMP
UCP BIOSCIENCES, INC.
U-CUP-1264-RCN
In Commercial Distribution

  • 20817038020627 ()
  • 10817038020620 ()
  • 00817038020623 ()
U-CUP-1264-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Screening Test Cup BZO/COC/OPI300/OXY/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-1164-RCN
In Commercial Distribution

  • 20817038020597 ()
  • 10817038020590 ()
  • 00817038020593 ()
U-CUP-1164-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Screening Test Cup BZO/COC/THC/MET/OPI300/AMP
UCP BIOSCIENCES, INC.
U-CUP-1064-RCN
In Commercial Distribution

  • 20817038020573 ()
  • 10817038020576 ()
  • 00817038020579 ()
U-CUP-1064-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 4 Panel Dip Card AMP/COC/THC/MET
UCP BIOSCIENCES, INC.
U-DOA-244
In Commercial Distribution

  • 20817038022164 ()
  • 10817038022167 ()
  • 00817038022160 ()
U-DOA-244

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card TM Drug Test Screen 3 panel Test Card COC/MET/THC
UCP BIOSCIENCES, INC.
U-DOA-234L
In Commercial Distribution

  • 20817038021952 ()
  • 10817038021955 ()
  • 00817038021958 ()
U-DOA-234L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards MDMA Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MDMA-114
In Commercial Distribution

  • 20817038021914 ()
  • 10817038021917 ()
  • 00817038021910 ()
U-MDMA-114

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards OXY Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OXY-114
In Commercial Distribution

  • 20817038021709 ()
  • 10817038021702 ()
  • 00817038021705 ()
U-OXY-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards AMP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-AMP-114
In Commercial Distribution

  • 20817038021570 ()
  • 10817038021573 ()
  • 00817038021576 ()
U-AMP-114

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards PCP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-PCP-114
In Commercial Distribution

  • 20817038021563 ()
  • 10817038021566 ()
  • 00817038021569 ()
U-PCP-114

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
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