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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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
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
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
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
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC
Ls Enterprises, Inc.
2520MCC-G
In Commercial Distribution

  • D0692520MCCG0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC
Ls Enterprises, Inc.
2520MCC
In Commercial Distribution

  • D0692520MCC0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, UNDER WORKSURFACE PANEL CONTROL
Ls Enterprises, Inc.
2186
In Commercial Distribution

  • D06921860 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, VERTICAL MOUNT PANEL CONTROL
Ls Enterprises, Inc.
2184
In Commercial Distribution

  • D06921840 ()


  • Dental delivery system
GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,XL
MEDLINE INDUSTRIES, INC.
MDTAUSGXP4OXL
In Commercial Distribution

  • 10888277418172 ()
MDTAUSGXP4OXL

  • Surgical gown, reusable
GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,L
MEDLINE INDUSTRIES, INC.
MDTAUSGXP4OL
In Commercial Distribution

  • 10888277418165 ()
MDTAUSGXP4OL

  • Surgical gown, reusable
D/L, E500 CONTROL PANEL MODULE, US VERSION
Covidien LP
186-0199R-SF
In Commercial Distribution

  • 10884521713055 ()


  • Neurophysiologic monitoring system
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/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/PCP/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020016
In Commercial Distribution

  • 10858904006485 ()
  • 00858904006488 ()
DOA-764-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
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
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,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
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
Visual-ICE™ MRI Mobile Connection Panel Zero Cost
BOSTON SCIENTIFIC CORPORATION
H74939700Z71000
In Commercial Distribution

  • 00191506036560 ()
H74939700Z71000

  • General cryosurgical system, cryogen gas, electronic
TR2810 US Shower panel with thermostatic mixer / Lock
Tr Equipment AB
0520072
In Commercial Distribution

  • 07350016061117 ()


  • Bathing/changing table, mobile
GOWN,SURG,XALT,L3,PANEL CVR,GREEN,XL
MEDLINE INDUSTRIES, INC.
MDTGXP3JXL
In Commercial Distribution

  • 30884389189218 ()
  • 10884389189214 ()
MDTGXP3JXL

  • Surgical gown, reusable
CVi bed mount control panel, p/n 700130-005
ACIST MEDICAL SYSTEMS, INC.
014607
In Commercial Distribution

  • 30841716101022 ()


  • Angiography contrast medium injection system, line-powered, mobile
GOWN,SURG,XALT,L3,PANEL CVR,GREEN,XX
MEDLINE INDUSTRIES, INC.
MDTGXP3JXXL
In Commercial Distribution

  • 40884389193304 ()
  • 10884389193303 ()
MDTGXP3JXXL

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

  • 40884389189222 ()
  • 10884389189221 ()
MDTGXP4JXL

  • Surgical gown, reusable
GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L
MEDLINE INDUSTRIES, INC.
MDTGXP4JL
In Commercial Distribution

  • 40888277189219 ()
  • 10888277189218 ()
MDTGXP4JL

  • Surgical gown, reusable
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
GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,XL
MEDLINE INDUSTRIES, INC.
MDTAUSGXP4OXL
In Commercial Distribution

  • 20888277418179 ()
  • 10888277418172 ()
MDTAUSGXP4OXL

  • Surgical gown, reusable
GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,L
MEDLINE INDUSTRIES, INC.
MDTAUSGXP4OL
In Commercial Distribution

  • 20888277418162 ()
  • 10888277418165 ()
MDTAUSGXP4OL

  • Surgical gown, reusable
Arctic Sun® 5000 Control Panel Screen Protector
Medivance, Inc.
75300
In Commercial Distribution

  • 00801741080470 ()
75300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Drugs of Abuse Test 10-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-8105A3
In Commercial Distribution

  • 40612479228823 ()
  • 20612479228812 ()
  • 10612479231013 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 14-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-1145A3
In Commercial Distribution

  • 40612479228809 ()
  • 20612479228799 ()
  • 10612479231006 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 12-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-6125A3
In Commercial Distribution

  • 40612479228786 ()
  • 20612479228775 ()
  • 10612479230993 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 12-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-5125A3
In Commercial Distribution

  • 40612479228762 ()
  • 20612479228751 ()
  • 10612479230986 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Sample Collection Kit, Blood (Adx Dual), Liver Panel
Cue Health Inc.
C2233
In Commercial Distribution

  • 00810040821080 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Single), Kidney Panel
Cue Health Inc.
C2236
In Commercial Distribution

  • 00810040821004 ()


  • Capillary blood collection kit IVD
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
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