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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ABDOMINAL BINDER 9IN 3 PANEL REG(30IN- 45IN)
TETRA MEDICAL SUPPLY CORP.
260000
In Commercial Distribution

  • 00614138025370 ()
260000

  • Abdominal binder, reusable
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
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/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 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
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
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
11 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Zerochaos
61113-3 ZC
Not in Commercial Distribution

  • B539611133ZC0 ()
61113-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Zerochaos
61020-3 ZC
In Commercial Distribution

  • B539610203ZC10 ()
61020-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Zerochaos
61020-3 ZC
Not in Commercial Distribution

  • B539610203ZC0 ()
61020-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Zerochaos
60967-3-ZC
In Commercial Distribution

  • B539609673ZC10 ()
60967-3-ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Zerochaos
60967-3-ZC
Not in Commercial Distribution

  • B539609673ZC0 ()
60967-3-ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
Zerochaos
60505-3 ZC
In Commercial Distribution

  • B539605053ZC10 ()
60505-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
Zerochaos
60505-3 ZC
Not in Commercial Distribution

  • B539605053ZC0 ()
60505-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
5 Panel OralTox - COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80510
Not in Commercial Distribution

  • B313OT805101 ()
  • B313OT805100 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - AMP/COC/MET/OPI/THC
PREMIER BIOTECH, INC
OT80508
Not in Commercial Distribution

  • B313OT805081 ()
  • B313OT805080 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - AMP/COC/OPI/PCP/THC
PREMIER BIOTECH, INC
OT80504
Not in Commercial Distribution

  • B313OT805041 ()
  • B313OT805040 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - AMP/COC/MET/OPI/THC
PREMIER BIOTECH, INC
OT80502
Not in Commercial Distribution

  • B313OT805021 ()
  • B313OT805020 ()


  • 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 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
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