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 Handpiece Motor
W & H Dentalwerk Bürmoos GmbH
30178000
In Commercial Distribution

  • J021301780001 ()


  • Dental surgical power tool motor, electric
  • Dental delivery system instrument unit, electric
No Description
J. W. HARRIS CO., INC.
REG,723C-050P PANEL MT
In Commercial Distribution

  • 00850005066538 ()
3500750

  • Medical air cylinder regulator
No Description
J. W. HARRIS CO., INC.
REG,723C-015LPM PANEL MT
In Commercial Distribution

  • 00850005066521 ()
3500749

  • Medical air cylinder regulator
No Description
BREG, INC.
EXTENSION PANEL, PINNACLE BELT
In Commercial Distribution

  • 00672736136867 ()
SP20010-000

  • Lumbar spine orthosis
No Description
BREG, INC.
EXTENSION PANEL, ASCEND BELT
In Commercial Distribution

  • 00672736136775 ()
SP10010-000

  • Lumbar spine orthosis
No Description
LivaNova Deutschland GmbH
Panel 6 pos. (S5)
In Commercial Distribution

  • 04033817900788 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Panel 3 pos. (S5)
In Commercial Distribution

  • 04033817900771 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Panel 5 pos. (S5)
In Commercial Distribution

  • 04033817900764 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Panel 4 pos. (S5)
In Commercial Distribution

  • 04033817900757 ()


  • Cardiopulmonary bypass system, roller type
Assisted Reproduction Microtools (Pipettes)
Coopersurgical, Inc.
145µm
In Commercial Distribution

  • 05060488047251 ()
7-72-3145/20

  • HLA class II antibody identification panel IVD, kit, multiplex
E SERIES DL LT Single Flat Panel Monitor AUX 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

  • 00724995172152 ()
LES03

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
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
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
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
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 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 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
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
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-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-AZ10
In Commercial Distribution

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

  • 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
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