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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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 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
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 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 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 ECSTASY (MDMA)
REDWOOD TOXICOLOGY LABORATORY, INC.
011020036
In Commercial Distribution

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

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CP-OF Panel, 3X, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100151
In Commercial Distribution

  • 00810042681149 ()
18100151

  • Multiple drugs of abuse IVD, control
CP-OF Panel, +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100150
In Commercial Distribution

  • 00810042681132 ()
18100150

  • Multiple drugs of abuse IVD, control
CP-OF Panel, -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100149
In Commercial Distribution

  • 00810042681125 ()
18100149

  • Multiple drugs of abuse IVD, control
9 Panel CUTOFF 5mL
BIOCHEMICAL DIAGNOSTICS INC
18002908
In Commercial Distribution

  • 00810042680296 ()
18002908

  • Multiple drugs of abuse IVD, control
Toxicology Evaluation Panel II
BIOCHEMICAL DIAGNOSTICS INC
26797
In Commercial Distribution

  • 00810042683822 ()
26797

  • Multiple drugs of abuse IVD, control
5 Panel DrugTest Cup
Healgen Scientific Limited Liability Company
HCDOAA-155
In Commercial Distribution

  • 20816490022248 ()
  • 10816490022241 ()
  • 00816490022244 ()
HCDOAA-155

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ANNUNCIATOR,REMOTE PANEL,PC6K
Crest Healthcare Supply
18B600R
In Commercial Distribution

  • B48418B600R0 ()


  • Nurse call system
CardioChek Lipid Panel Test
HENRY SCHEIN, INC.
5700414
In Commercial Distribution

  • 10304040037741 ()
  • 00304040037744 ()
5700414

  • Multiple lipid analyte IVD, kit, spectrophotometry
MMR IHC Panel Antibody
Ventana Medical Systems, Inc.
790-5091
In Commercial Distribution

  • 07613336100561 ()
07862237001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MLH1 protein IVD, antibody
Assayed Respiratory Control Panel
MICROBIOLOGICS INC.
8199 Cepheid Xpert® Respiratory Control Panel
In Commercial Distribution

  • 70845357041240 ()
8199

  • Multiple-genus respiratory virus nucleic acid IVD, control
DISPOSABLE ZIP-TOP X-RAY PANEL/
Techno-Aide, Inc.
CCZ-14
In Commercial Distribution

  • G242CCZ1491 ()
  • G242CCZ149 ()
CCZ-14

  • Medical equipment/instrument drape, single-use
DELTA 2.2MM PANEL 116x17x1.4MM
Stryker Leibinger GmbH & Co. KG
70-92020
In Commercial Distribution

  • 07613252529002 ()

  • Width: 17.0 Millimeter
  • Length: 116.0 Millimeter
  • Thickness: 1.4 Millimeter
70-92020

  • Craniofacial fixation plate, bioabsorbable
DELTA 2.2MM PANEL 116x11x1.4MM
Stryker Leibinger GmbH & Co. KG
70-92019
In Commercial Distribution

  • 07613252528999 ()

  • Width: 11.0 Millimeter
  • Length: 116.0 Millimeter
  • Thickness: 1.4 Millimeter
70-92019

  • Craniofacial fixation plate, bioabsorbable
Delta 1.7mm Panel 122x122x0.75mm
Stryker Leibinger GmbH & Co. KG
70-92012
In Commercial Distribution

  • 07613252448808 ()

  • Thickness: 0.75 Millimeter
  • Length: 122.0 Millimeter
  • Width: 122.0 Millimeter
70-92012

  • Craniofacial fixation plate, bioabsorbable
KIT, RETAINING, HEAD PANEL
JOERNS HEALTHCARE, LLC
N495AL
In Commercial Distribution

  • 00810055882724 ()
N495AL

  • Basic electric hospital bed
KIT, RETAINING, FOOT PANEL
JOERNS HEALTHCARE, LLC
N494AL
In Commercial Distribution

  • 00810055882717 ()
N494AL

  • Basic electric hospital bed
CT/NG Verification Panel
EXACT DIAGNOSTICS, LLC
CTNGP200
In Commercial Distribution

  • 00812242030741 ()
CTNGP200

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control
HBV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HBVP200
In Commercial Distribution

  • 00812242030673 ()
HBVP200

  • Hepatitis B virus nucleic acid IVD, calibrator
HCV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HCVP200
In Commercial Distribution

  • 00812242030635 ()
HCVP200

  • Hepatitis C virus nucleic acid IVD, calibrator
CMV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
CMVP200
In Commercial Distribution

  • 00812242030598 ()
CMVP200

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
HIV-1 Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HIVP200
In Commercial Distribution

  • 00812242030550 ()
HIVP200

  • HIV1 nucleic acid IVD, calibrator
Parvovirus B19 Verification Panel
EXACT DIAGNOSTICS, LLC
B19P100
In Commercial Distribution

  • 00812242030475 ()
B19P100

  • Parvovirus B19 nucleic acid IVD, calibrator
KIT, PANEL, PL691, 5-PCS
Securitas Healthcare LLC
RP131K
In Commercial Distribution

  • 00812664024137 ()
  • 00812664023710 ()
RP131K

  • Nurse call system alarm
THL Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN262
In Commercial Distribution

  • 00817100020339 ()


  • Diagnostic x-ray digital imaging conversion system
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-15BX-A
In Commercial Distribution

  • 10816862022305 ()
  • 00816862022308 ()
  • 00816862022315 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-5BX-A
In Commercial Distribution

  • 00816862022292 ()
  • 00816862022278 ()
  • 00816862022285 ()


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