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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OEC Disposables, 31cm Flat Panel CFD OEC One
TIDI PRODUCTS, LLC
33326
In Commercial Distribution

  • 10618125190048 ()
  • 00618125190041 ()
5857958

  • Medical equipment/instrument drape, single-use
OEC Disposables, 21cm Flat Panel CFD OEC One
TIDI PRODUCTS, LLC
33325
In Commercial Distribution

  • 10618125189325 ()
  • 00618125189328 ()
5845457

  • Medical equipment/instrument drape, single-use
Slimax-C Plus,Pink,Cordless, Display Panel, Built-in Radiometer
Beyes Dental Canada Inc
SM1003P-PI
In Commercial Distribution

  • 00990010301962 ()
Slimax-C Plus

  • Dental/surgical polymerization lamp
Slimax-C Plus,Blue,Cordless, Display Panel, Built-in Radiometer
Beyes Dental Canada Inc
SM1003P-B
In Commercial Distribution

  • 00990010301955 ()
Slimax-C Plus

  • Dental/surgical polymerization lamp
Slimax-C Plus, Sliver, Cordless, Display Panel, Built-in Radiometer
Beyes Dental Canada Inc
SM1003P-S
In Commercial Distribution

  • 00990010301979 ()
Slimax-C Plus

  • Dental/surgical polymerization lamp
Alere Triage® Cardiac Panel, CK-MB and TnI
ALERE SAN DIEGO, INC.
97022HS
Not in Commercial Distribution

  • 00899722002795 ()
97022HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Slimax-C Plus, Sliver, Cordless, Display Panel, Built-in Radiometer
Beyes Dental Canada Inc
SM1003P-S
In Commercial Distribution

  • 00837699000789 ()


  • Dental/surgical polymerization lamp
Slimax-C Plus,Pink,Cordless, Display Panel, Built-in Radiometer
Beyes Dental Canada Inc
SM1003P-PI
In Commercial Distribution

  • 00837699000772 ()


  • Dental/surgical polymerization lamp
Slimax-C Plus,Blue,Cordless, Display Panel, Built-in Radiometer
Beyes Dental Canada Inc
SM1003P-B
In Commercial Distribution

  • 00837699000765 ()


  • Dental/surgical polymerization lamp
8 panel Rapid Tox opi 300 with SVT
AMERICAN BIO MEDICA CORPORATION
10-8XTA-030
In Commercial Distribution

  • 10694644100232 ()
  • 10694644150237 ()
10-8XTA-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Respiratory Panel Viral Screening and Identification DFA Kit
EMD Millipore Corporation
3137
Not in Commercial Distribution

  • 08436037124631 ()
3137

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Respiratory Panel Viral Screening and Identification IFA Kit
EMD Millipore Corporation
3105
Not in Commercial Distribution

  • 08436037122651 ()
3105

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
PANEL 06 COC150/AMP1000/MAMP500/THC/MOP300/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020203
In Commercial Distribution

  • 10858904006638 ()
  • 00858904006631 ()
DOA-164-1551

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 6 COC/M-AMP/THC/OPI/PCP/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020016
In Commercial Distribution

  • 10858904006485 ()
  • 00858904006488 ()
DOA-764-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
D/L, E500 CONTROL PANEL MODULE, US VERSION
Covidien LP
186-0199R-SF
In Commercial Distribution

  • 10884521713055 ()


  • Neurophysiologic monitoring system
Visual-ICE™ MRI Mobile Connection Panel Zero Cost
BOSTON SCIENTIFIC CORPORATION
H74939700Z71000
In Commercial Distribution

  • 00191506036560 ()
H74939700Z71000

  • General cryosurgical system, cryogen gas, electronic
GOWN,SRI,XALT/BLKD,PANEL CVR,GRN,L
MEDLINE INDUSTRIES, INC.
SYN7403L
In Commercial Distribution

  • 40884389193489 ()
  • 10884389193488 ()
SYN7403L

  • Surgical gown, reusable
GOWN,SURG,XALT,L3,PANEL CVR,GREEN,XX
MEDLINE INDUSTRIES, INC.
MDTGXP3JXXL
In Commercial Distribution

  • 10884389193303 ()
MDTGXP3JXXL

  • Surgical gown, reusable
GOWN,SRI,XALT/BLKD,PANEL CVR,GRN,XXL
MEDLINE INDUSTRIES, INC.
SYN7405XXL
In Commercial Distribution

  • 40884389172248 ()
  • 10884389172247 ()
SYN7405XXL

  • Surgical gown, reusable
GOWN,SRI,XALT/BLKD,PANEL CVR,GRN,M
MEDLINE INDUSTRIES, INC.
SYN7402M
In Commercial Distribution

  • 40884389172231 ()
  • 10884389172230 ()
SYN7402M

  • Surgical gown, reusable
GOWN,SRI,XALT/BLKD,PANEL CVR,GRN,S
MEDLINE INDUSTRIES, INC.
SYN7401S
In Commercial Distribution

  • 40884389172224 ()
  • 10884389172223 ()
SYN7401S

  • Surgical gown, reusable
GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,XL
MEDLINE INDUSTRIES, INC.
MDTGXP4OXL
In Commercial Distribution

  • 10884389189238 ()
MDTGXP4OXL

  • Surgical gown, reusable
GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL
MEDLINE INDUSTRIES, INC.
MDTGXP4JXL
In Commercial Distribution

  • 10884389189221 ()
MDTGXP4JXL

  • Surgical gown, reusable
GOWN,SURG,XALT,L3,PANEL CVR,GREEN,XL
MEDLINE INDUSTRIES, INC.
MDTGXP3JXL
In Commercial Distribution

  • 10884389189214 ()
MDTGXP3JXL

  • Surgical gown, reusable
PANEL 6 COC/M-AMP/THC/MTD/OPI/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020017
In Commercial Distribution

  • 10858904006508 ()
  • 00858904006501 ()
DOA-864-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 6 COC/M-AMP/THC/OPI/BAR/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020024
In Commercial Distribution

  • 10858904006492 ()
  • 00858904006495 ()
DOA-964-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 06 COC150/BZO/MAMP500/OPI300/MDMA/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020175
In Commercial Distribution

  • 10858904006331 ()
  • 00858904006334 ()
DOA-164-1491

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 06 COC150/AMP300/MAMP500/OPI300/MDMA/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020174
In Commercial Distribution

  • 10858904006324 ()
  • 00858904006327 ()
DOA-164-1481

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 6 COC/M-AMP/THC/OPI/OXY/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020119
In Commercial Distribution

  • 10858904006317 ()
  • 00858904006310 ()
DOA-164-341

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX
CLINICAL REFERENCE LABORATORY, INC.
51013
Not in Commercial Distribution

  • 81781502510130 ()
51013

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-THC-pH,SG,OX
CLINICAL REFERENCE LABORATORY, INC.
51003
Not in Commercial Distribution

  • 81781502510031 ()
51003

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Cepheid Xpert® C. difficile/Epi Control Panel
MICROBIOLOGICS INC.
8200 Cepheid Xpert® C. difficile/Epi Control Panel
In Commercial Distribution

  • 70845357041370 ()
8200

  • Clostridium difficile nucleic acid IVD, control
BD MAX™ Enteric Parasite 20-Day QC Panel
MICROBIOLOGICS INC.
8202 BD MAX™ Enteric Parasite 20-Day QC Panel
In Commercial Distribution

  • 70845357041097 ()
8202

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
11 Panel Cup Drug Test, AMP500-BUP-BZO-COC150-EDDP300-MDMA-MET500-MTD-OPI300-OXY-THC-pH,SG,OX
Express Diagnostic Int'l, Inc.
71130-3
In Commercial Distribution

  • B29871130310 ()
71130-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP500-BUP-BZO-COC150-EDDP300-MDMA-MET500-MTD-OPI300-OXY-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
71130-3
Not in Commercial Distribution

  • B2987113030 ()
71130-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP500-BUP-BZO-COC150-EDDP-MDMA-MET500-MTD-OPI300-OXY-pH,SG,OX
Express Diagnostic Int'l, Inc.
71022-3
In Commercial Distribution

  • B29871022310 ()
71022-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-PCP-THC-pH,SG,OX
Express Diagnostic Int'l, Inc.
71021-3
In Commercial Distribution

  • B29871021310 ()
71021-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, BZO-COC-MET-OPI-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
65515-3
Not in Commercial Distribution

  • B2986551530 ()
65515-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
Express Diagnostic Int'l, Inc.
65505-3
In Commercial Distribution

  • B29865505310 ()
65505-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
65505-3
In Commercial Distribution

  • B2986550530 ()
65505-3

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