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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LIVE VIEW PANEL SYSTEM
NIHON KOHDEN AMERICA, INC.
A/LVP
In Commercial Distribution

  • 00841983103858 ()
A/LVP

  • Electroencephalograph
NEUROFAX ACQUISITION, PANEL PC
NIHON KOHDEN AMERICA, INC.
EEG-1250A
In Commercial Distribution

  • 00841983103797 ()
EEG-1250A

  • Electroencephalograph
Viking Control Panel - French
NATUS NEUROLOGY INCORPORATED
842-129800
In Commercial Distribution

  • 00382830034494 ()


  • Electromyograph
Viking EDX Control Panel
NATUS NEUROLOGY INCORPORATED
842-689400
In Commercial Distribution

  • 00382830033893 ()


  • Electromyograph
EMG USB Control Panel
NATUS NEUROLOGY INCORPORATED
515-016700
In Commercial Distribution

  • 00382830041560 ()


  • Electromyograph
Viking Control Panel - German
NATUS NEUROLOGY INCORPORATED
842-129700
In Commercial Distribution

  • 00382830034500 ()


  • Electromyograph
Synergy EDX Control Panel
NATUS NEUROLOGY INCORPORATED
842-689500
In Commercial Distribution

  • 00382830033879 ()


  • Electromyograph
SPINOMED ANTERIOR PANEL SET
MEDI MANUFACTURING, INC.
RKIT9201
In Commercial Distribution

  • 00636257095850 ()


  • Lumbar spine orthosis
Ready-Heat 6 Panel Blanket
TECHTRADE, LLC
S6RHLG
In Commercial Distribution

  • 00850017905122 ()
  • 00850017905023 ()


  • Hot/cold therapy pack, single-use
  • Bed blanket, single-use
PATCH PANEL FOR 80247
PENTAX OF AMERICA, INC.
80259
In Commercial Distribution

  • 04961333241163 ()


  • Transportable medical equipment stand, non-powered
DELTA 2.2MM PANEL 55X55X1.4MM
Stryker Leibinger GmbH & Co. KG
70-06355
In Commercial Distribution

  • 04546540337344 ()

  • Thickness: 1.4 Millimeter
  • Width: 55.0 Millimeter
  • Length: 55.0 Millimeter
70-06355

  • Craniofacial fixation plate, bioabsorbable
DELTA 1.7MM PANEL 55X55X1.0MM
Stryker Leibinger GmbH & Co. KG
70-05355
In Commercial Distribution

  • 04546540337214 ()

  • Thickness: 1.0 Millimeter
  • Length: 55.0 Millimeter
  • Width: 55.0 Millimeter
70-05355

  • Craniofacial fixation plate, bioabsorbable
Respiratory Panel DFA Kit
EMD Millipore Corporation
3110
Not in Commercial Distribution

  • 04053252362064 ()
3110

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Men's Wellness Panel Kit
Cardinal Health 200, LLC
AMM1955
In Commercial Distribution

  • 10810010891348 ()
AMM1955

  • Phlebotomy kit
Complete Lipid Panel Kit
Cardinal Health 200, LLC
AMM1953
In Commercial Distribution

  • 10810010891324 ()
AMM1953

  • Phlebotomy kit
Plate Panel, Heavy, 0.6mm
Kinamed, Inc.
14-1P3-8622
In Commercial Distribution

  • 00898142001173 ()
14-1P3-8622

  • Cranioplasty sheet
Plate Panel, Heavy, 0.6mm
Kinamed, Inc.
14-1P3-8615
In Commercial Distribution

  • 00898142001142 ()
14-1P3-8615

  • Cranioplasty sheet
DISPOSABLE ZIP-TOP X-RAY PANEL/
Techno-Aide, Inc.
CCZ-14
In Commercial Distribution

  • G242CCZ1491 ()
  • G242CCZ149 ()
CCZ-14

  • Medical equipment/instrument drape, single-use
PANEL 1 BUP buprenorphine
REDWOOD TOXICOLOGY LABORATORY, INC.
011020173
In Commercial Distribution

  • 10858904006645 ()
  • 00858904006648 ()
DUB-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 02 MAMP500/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020192
In Commercial Distribution

  • 10858904006546 ()
  • 00858904006549 ()
DOA-124-311

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 02 COC150/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020191
In Commercial Distribution

  • 10858904006539 ()
  • 00858904006532 ()
DOA-124-201

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 01 MAMP 500
REDWOOD TOXICOLOGY LABORATORY, INC.
011020190
In Commercial Distribution

  • 10858904006522 ()
  • 00858904006525 ()
DMA-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 01 COC 150
REDWOOD TOXICOLOGY LABORATORY, INC.
011020189
In Commercial Distribution

  • 10858904006515 ()
  • 00858904006518 ()
DOA-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 2 COC/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020006
In Commercial Distribution

  • 10858904006171 ()
  • 00858904006174 ()
DOA-124-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 2 COC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020005
In Commercial Distribution

  • 10858904006140 ()
  • 00858904006143 ()
DOA-224-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 2 M-AMP/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020030
In Commercial Distribution

  • 10858904006133 ()
  • 00858904006136 ()
DOA-824-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 OXYCODONE (OXY)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020037
In Commercial Distribution

  • 10858904006119 ()
  • 00858904006112 ()
DOX-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 METHADONE (MTD)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020020
In Commercial Distribution

  • 10858904006072 ()
  • 00858904006075 ()
DMT-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 OPIATES (OPI)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020003
In Commercial Distribution

  • 10858904006065 ()
  • 00858904006068 ()
DMO-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 ECSTASY (MDMA)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020036
In Commercial Distribution

  • 10858904006058 ()
  • 00858904006051 ()
DMD-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 COCAINE (COC)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020001
In Commercial Distribution

  • 10858904006041 ()
  • 00858904006044 ()
DCO-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 BENZODIAZEPINE (BZO)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020022
In Commercial Distribution

  • 10858904006034 ()
  • 00858904006037 ()
DBZ-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 BARBITURATE (BAR)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020019
In Commercial Distribution

  • 10858904006027 ()
  • 00858904006020 ()
DBA-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 AMPHETAMINE (AMP)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020018
In Commercial Distribution

  • 10858904006010 ()
  • 00858904006013 ()
DAM-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Post Mount Heavy Panel
Conmed Corporation
VP8565
In Commercial Distribution

  • 10845854028995 ()
VP8565

  • Medical device integration rack
AMPHETAMINES PANEL LEVEL 2
UTAK LABORATORIES, INC.
AMPH 2 U F UW
In Commercial Distribution

  • B800AMPH2UFUW5 ()
  • B800AMPH2UFUW0 ()

  • Total Volume: .32 Milliliter
AMPH 2 U F UW

  • Multiple drugs of abuse IVD, control
AMPHETAMINES PANEL LEVEL 1
UTAK LABORATORIES, INC.
AMPH 1 U F UW
In Commercial Distribution

  • B800AMPH1UFUW5 ()
  • B800AMPH1UFUW0 ()

  • Total Volume: .32 Milliliter
AMPH 1 U F UW

  • Multiple drugs of abuse IVD, control
Miscellaneous Panel Level 2
UTAK LABORATORIES, INC.
41431
In Commercial Distribution

  • B800414315 ()
  • B800414310 ()

  • Total Volume: 5 Milliliter
41431

  • Multiple drugs of abuse IVD, control
Miscellaneous Panel Level 1
UTAK LABORATORIES, INC.
41430
In Commercial Distribution

  • B800414305 ()
  • B800414300 ()

  • Total Volume: 5 Milliliter
41430

  • Multiple drugs of abuse IVD, control
Amphetamines Panel Level 2
UTAK LABORATORIES, INC.
41401
In Commercial Distribution

  • B800414015 ()
  • B800414010 ()

  • Total Volume: 5 Milliliter
41401

  • Amphetamine/methamphetamine group IVD, control
Amphetamines Panel Level 1
UTAK LABORATORIES, INC.
41400
In Commercial Distribution

  • B800414005 ()
  • B800414000 ()

  • Total Volume: 5 Milliliter
41400

  • Amphetamine/methamphetamine group IVD, control
URINE BROAD PANEL MID
UTAK LABORATORIES, INC.
UBP M F DU
In Commercial Distribution

  • B800UBPMFDU5 ()
  • B800UBPMFDU0 ()

  • Total Volume: 1 Milliliter
UBP M F DU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
URINE BROAD PANEL LOW
UTAK LABORATORIES, INC.
UBP L F DU
In Commercial Distribution

  • B800UBPLFDU5 ()
  • B800UBPLFDU0 ()

  • Total Volume: 1 Milliliter
UBP L F DU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
URINE BROAD PANEL HIGH
UTAK LABORATORIES, INC.
UBP H F V DU
In Commercial Distribution

  • B800UBPHFVDU5 ()
  • B800UBPHFVDU0 ()

  • Total Volume: 1 Milliliter
UBP H F V DU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
URINE BROAD PANEL HIGH
UTAK LABORATORIES, INC.
UBP H F DU
In Commercial Distribution

  • B800UBPHFDU5 ()
  • B800UBPHFDU0 ()

  • Total Volume: 1 Milliliter
UBP H F DU

  • Multiple-type clinical chemistry analyte profile IVD, control
TCA PANEL LEVEL 3
UTAK LABORATORIES, INC.
TCA 3 U WBH
In Commercial Distribution

  • B800TCA3UWBH5 ()
  • B800TCA3UWBH0 ()

  • Total Volume: 5 Milliliter
TCA 3 U WBH

  • Multiple drugs of abuse IVD, control
PSYCH PANEL LEVEL 2
UTAK LABORATORIES, INC.
PSYCH 2 F M ACL
In Commercial Distribution

  • B800PSYCH2FMACL5 ()
  • B800PSYCH2FMACL0 ()

  • Total Volume: 3 Milliliter
PSYCH 2 F M ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
PSYCH PANEL LEVEL 1
UTAK LABORATORIES, INC.
PSYCH 1 F M ACL
In Commercial Distribution

  • B800PSYCH1FMACL5 ()
  • B800PSYCH1FMACL0 ()

  • Total Volume: 3 Milliliter
PSYCH 1 F M ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PANEL POSITIVE 2
UTAK LABORATORIES, INC.
FENT+ POS2 U KP
In Commercial Distribution

  • B800FENTPOS2UKP5 ()
  • B800FENTPOS2UKP0 ()

  • Total Volume: 10 Microliter
FENT+ POS2 U KP

  • Multiple drugs of abuse IVD, control
FENTANYL PANEL POSITIVE 1
UTAK LABORATORIES, INC.
FENT+ POS1 U KP
In Commercial Distribution

  • B800FENTPOS1UKP5 ()
  • B800FENTPOS1UKP0 ()

  • Total Volume: 10 Microliter
FENT+ POS1 U KP

  • Multiple drugs of abuse IVD, control
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