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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Drug Cup 13 Panel Plus AD Test
Prabadin Corp
PR48Y5-CUP
In Commercial Distribution

  • 10850051158086 ()
  • 00850051158089 ()
  • 00850051158102 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 235 128MM X 79MM X .025
MEDTRONIC PS MEDICAL, INC.
235
In Commercial Distribution

  • 00643169620674 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-152 CRANIAL MESH 152 X 152MM
MEDTRONIC PS MEDICAL, INC.
016-152
In Commercial Distribution

  • 00643169620643 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-128 CRANIAL MESH 128 X 79MM
MEDTRONIC PS MEDICAL, INC.
016-128
In Commercial Distribution

  • 00643169620636 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-100 CRANIAL MESH 100 X 100MM
MEDTRONIC PS MEDICAL, INC.
016-100
In Commercial Distribution

  • 00643169620612 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-200 CRANIAL MESH 200 X 200MM
MEDTRONIC PS MEDICAL, INC.
016-200
In Commercial Distribution

  • 00643169620650 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-120 CRANIAL MESH 120 X 120MM
MEDTRONIC PS MEDICAL, INC.
016-120
In Commercial Distribution

  • 00643169620629 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 235 128MM X 79MM X .025
MEDTRONIC PS MEDICAL, INC.
235
In Commercial Distribution

  • 00673978014562 ()

  • Width: 79.0 Millimeter
  • Height: 0.6 Millimeter
  • Length: 128.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
1066, ACP Astera 2 (Audiometer Control Panel)
Natus Medical Denmark ApS
1066, ACP ASTERA 2
In Commercial Distribution

  • 05713315004988 ()
8-69-40800

  • Speech audiometer
2 mode small panel light therapy device
Biophotas, Inc.
Series 2 HOME C/US
In Commercial Distribution

  • 00850523007747 ()
CPM2-001

  • Blue/red/infrared phototherapy lamp
3 mode small panel light therapy device
Biophotas, Inc.
Series 2 RESTORE C/US
In Commercial Distribution

  • 00850523007730 ()
CLR2-001

  • Blue/red/infrared phototherapy lamp
4 mode small panel light therapy device
Biophotas, Inc.
Series 2 LITE C/US
In Commercial Distribution

  • 00850523007723 ()
CML2-001

  • Blue/red/infrared phototherapy lamp
3 mode large panel light therapy device
Biophotas, Inc.
Series 2 PRO C/US
In Commercial Distribution

  • 00850523007716 ()
CLP2-001

  • Blue/red/infrared phototherapy lamp
4 mode large panel light therapy device
Biophotas, Inc.
Series 2 PRO PLUS C/US
In Commercial Distribution

  • 00850523007709 ()
CPM2-001

  • Blue/red/infrared phototherapy lamp
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTOMATIC
Ls Enterprises, Inc.
2522MCC-G
In Commercial Distribution

  • D0692522MCCG0 ()


  • Dental delivery system
DR'S PANEL MOUNT, COMPACT CONTROL, 2-HANDPIECE AUTOMATIC
Ls Enterprises, Inc.
2520
In Commercial Distribution

  • D06925200 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC
Ls Enterprises, Inc.
2501MCC-G
In Commercial Distribution

  • D0692501MCCG0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC
Ls Enterprises, Inc.
2501MCC-C
In Commercial Distribution

  • D0692501MCCC0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC
Ls Enterprises, Inc.
2501MCC
In Commercial Distribution

  • D0692501MCC0 ()


  • Dental delivery system
DR'S PANEL MOUNT, COMPACT CONTROL, 3-HANDPIECE AUTOMATIC
Ls Enterprises, Inc.
2500
In Commercial Distribution

  • D06925000 ()


  • Dental delivery system
u-Card BZO Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BZO-114L
In Commercial Distribution

  • 20817038021402 ()
  • 10817038021405 ()
  • 00817038021408 ()
U-BZO-114L

  • Benzodiazepine group IVD, kit, rapid ICT, clinical
u-Card BAR Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BAR-114L
In Commercial Distribution

  • 20817038021396 ()
  • 10817038021399 ()
  • 00817038021392 ()
U-BAR-114L

  • Barbiturate IVD, kit, rapid ICT, clinical
u-Card MDMA Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MDMA-114L
In Commercial Distribution

  • 20817038021389 ()
  • 10817038021382 ()
  • 00817038021385 ()
U-MDMA-114L

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
u-Card COC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-COC-114L
In Commercial Distribution

  • 10817038021375 ()
  • 00817038021378 ()
  • 20817038021372 ()
U-COC-114L

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
OPI 2000 Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OPI-114
In Commercial Distribution

  • 20817038020474 ()
  • 10817038020477 ()
  • 00817038020470 ()
U-OPI-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
RFB FLAT PANEL LCD 19 NDS RADIANCE
Smith & Nephew, Inc.
72200020F
In Commercial Distribution

  • 03596010611598 ()
72200020F

  • Image display unit, colour
Flat Panel Digital Medical X-Ray Imaging Detector.
Imaging Dynamics Company Ltd
1717TC
In Commercial Distribution

  • 00823073002111 ()

  • Height: 15.5 Millimeter
  • Width: 460 Millimeter
  • Length: 460 Millimeter
  • Weight: 4.0 Kilogram


  • Diagnostic x-ray digital imaging conversion system
Alere Triage® Profiler SOB™ Panel
ALERE SAN DIEGO, INC.
97300EU
Not in Commercial Distribution

  • 00899722002740 ()
97300EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
1 Panel Home Drug Test Kit THC
CONFIRM BIOSCIENCES, INC.
RO-DRC001
In Commercial Distribution

  • 00895330002356 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
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