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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4 mode small panel light therapy device
Biophotas, Inc.
Series 2 LITE C/US
In Commercial Distribution

  • 00850523007723 ()
CML2-001

  • Blue/red/infrared phototherapy lamp
3 mode large panel light therapy device
Biophotas, Inc.
Series 2 PRO C/US
In Commercial Distribution

  • 00850523007716 ()
CLP2-001

  • Blue/red/infrared phototherapy lamp
4 mode large panel light therapy device
Biophotas, Inc.
Series 2 PRO PLUS C/US
In Commercial Distribution

  • 00850523007709 ()
CPM2-001

  • Blue/red/infrared phototherapy lamp
1066, ACP Astera 2 (Audiometer Control Panel)
Natus Medical Denmark ApS
1066, ACP ASTERA 2
In Commercial Distribution

  • 05713315004988 ()
8-69-40800

  • Speech audiometer
PANEL 016-200 CRANIAL MESH 200 X 200MM
MEDTRONIC PS MEDICAL, INC.
016-200
In Commercial Distribution

  • 00613994284655 ()

  • Width: 200.0 Millimeter
  • Length: 200.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-152 CRANIAL MESH 152 X 152MM
MEDTRONIC PS MEDICAL, INC.
016-152
In Commercial Distribution

  • 00613994284648 ()

  • Length: 152.0 Millimeter
  • Height: 0.6 Millimeter
  • Width: 152.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-128 CRANIAL MESH 128 X 79MM
MEDTRONIC PS MEDICAL, INC.
016-128
In Commercial Distribution

  • 00613994284631 ()

  • Length: 128.0 Millimeter
  • Width: 79.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-120 CRANIAL MESH 120 X 120MM
MEDTRONIC PS MEDICAL, INC.
016-120
In Commercial Distribution

  • 00613994284624 ()

  • Width: 120.0 Millimeter
  • Length: 120.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-100 CRANIAL MESH 100 X 100MM
MEDTRONIC PS MEDICAL, INC.
016-100
In Commercial Distribution

  • 00613994284617 ()

  • Length: 100.0 Millimeter
  • Width: 100.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
HYDRATHERM FUSE KIT CONTROL PANEL REPAIR PART
COMPASS HEALTH BRANDS CORP.
HT-TU-FUSEKIT
In Commercial Distribution

  • 00092237625491 ()


  • Hot therapy pack heating unit
OXY PANEL CLIA WAIVED DIP CARD OXY100
Instant Technologies, Inc.
ABTDOXW11401A
In Commercial Distribution

  • 30817405023784 ()
  • 00817405023783 ()
  • 10817405023780 ()
ABTDOXW11401A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Morphine (MOP) Single Drug Urine Test Panel
Instant Technologies, Inc.
AWDMO-114
In Commercial Distribution

  • 00817405021093 ()
AWDMO-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
To be used with MMR IHC Panel
Ventana Medical Systems, Inc.
790-5095
In Commercial Distribution

  • 07613336100608 ()
07862270001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
For use with the MMR IHC Panel
Ventana Medical Systems, Inc.
790-5093
In Commercial Distribution

  • 07613336100585 ()
07862253001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MSH2 antigen IVD, antibody
8 PANEL INCUP AMP/BAR/BZO/COC/
AMERICAN BIO MEDICA CORPORATION
10-8SPCA-220
In Commercial Distribution

  • 10694644400592 ()
  • 10694644450597 ()
10-8SPCA-220

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 PANEL INCUP WITH AMP/COC/OPI
AMERICAN BIO MEDICA CORPORATION
10-4SPCA-300
In Commercial Distribution

  • 10694644400226 ()
  • 10694644450221 ()
10-4SPCA-300

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 PANEL RDS WITH OXY/BUP/METH,
AMERICAN BIO MEDICA CORPORATION
10-3SPB-189
In Commercial Distribution

  • 10694644300168 ()
  • 10694644350163 ()
10-3SPB-189

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 panel w/Thc&Coc BULK PACK
AMERICAN BIO MEDICA CORPORATION
10-2CS-000
In Commercial Distribution

  • 10694644300106 ()
  • 10694644350101 ()
10-2CS-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 panel w/Coc & Meth Bulk pack
AMERICAN BIO MEDICA CORPORATION
10-2CMS-000
In Commercial Distribution

  • 10694644300090 ()
  • 10694644350095 ()
10-2CMS-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 Panel w/THC&CocSingle 25/BOX
AMERICAN BIO MEDICA CORPORATION
10-2C1-000
In Commercial Distribution

  • 10694644300076 ()
  • 10694644350071 ()
10-2C1-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 PANEL WITH MTD, PPX,BZO,BAR
AMERICAN BIO MEDICA CORPORATION
10-10ND1-030
In Commercial Distribution

  • 10694644300038 ()
  • 10694644350033 ()
10-10ND1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII MINI 12 panel + K2, FYL, ETG
AMERICAN BIO MEDICA CORPORATION
10-15BX3KFE-030
Not in Commercial Distribution

  • 10694644500247 ()
  • 10694644550242 ()
10-15BX3KFE-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII MINI 12 panel + TML, FYL, ETG
AMERICAN BIO MEDICA CORPORATION
10-15BX3TFE-030
Not in Commercial Distribution

  • 10694644500179 ()
  • 10694644550174 ()
10-15BX3TFE-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RDS 6 PANEL CARD ONLY OPI300/M
AMERICAN BIO MEDICA CORPORATION
10-6SPB-327
In Commercial Distribution

  • 10694644300502 ()
  • 10694644350507 ()
10-6SPB-327

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 panel test cup, COC/OPI2000/THC
AMEDITECH INC.
IMC-3P
Not in Commercial Distribution

  • 00816565020120 ()
IMC-3P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAV-10115
In Commercial Distribution

  • 20816490024006 ()
  • 10816490024009 ()
  • 00816490024002 ()
HCDOAV-10115

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAV-334
In Commercial Distribution

  • 20816490023856 ()
  • 10816490023859 ()
  • 00816490023852 ()
HCDOAV-334

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
GBDOAEW-6125
In Commercial Distribution

  • 20816490022750 ()
  • 10816490022753 ()
  • 00816490022756 ()
GBDOAEW-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAEW-254
In Commercial Distribution

  • 20816490022590 ()
  • 10816490022593 ()
  • 00816490022596 ()
HCDOAEW-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAEW-9125
In Commercial Distribution

  • 20816490022583 ()
  • 10816490022586 ()
  • 00816490022589 ()
HCDOAEW-9125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAEW-6125
In Commercial Distribution

  • 20816490022279 ()
  • 10816490022272 ()
  • 00816490022275 ()
HCDOAEW-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-6124
In Commercial Distribution

  • 20816490022118 ()
  • 10816490022104 ()
  • 00816490022107 ()
HCDOAF-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Clear Round Cup ;
Healgen Scientific Limited Liability Company
HCDOA-564
In Commercial Distribution

  • 20816490021982 ()
  • 10816490021985 ()
  • 00816490021988 ()
HCDOA-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup ;
Healgen Scientific Limited Liability Company
HCDOA-5125
In Commercial Distribution

  • 20816490021975 ()
  • 10816490021978 ()
  • 00816490021971 ()
HCDOA-5125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup ;
Healgen Scientific Limited Liability Company
HCDOA-254
In Commercial Distribution

  • 20816490021951 ()
  • 10816490021954 ()
  • 00816490021957 ()
HCDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup ;
Healgen Scientific Limited Liability Company
HCDOA-154
In Commercial Distribution

  • 20816490021944 ()
  • 10816490021947 ()
  • 00816490021940 ()
HCDOA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
17 Panel DOA Test clear Round Cup
Healgen Scientific Limited Liability Company
HCDOA-1174
In Commercial Distribution

  • 20816490021852 ()
  • 10816490021855 ()
  • 00816490021858 ()
HCDOA-1174

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-6125
In Commercial Distribution

  • 20816490021821 ()
  • 10816490021824 ()
  • 00816490021827 ()
HCDOAF-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-4104
In Commercial Distribution

  • 20816490021401 ()
  • 10816490021404 ()
  • 00816490021407 ()
HCDOAF-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-3104
In Commercial Distribution

  • 20816490021388 ()
  • 10816490021381 ()
  • 00816490021384 ()
HCDOAF-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-654
In Commercial Distribution

  • 20816490021371 ()
  • 10816490021374 ()
  • 00816490021377 ()
HCDOAF-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-254
In Commercial Distribution

  • 20816490021357 ()
  • 10816490021350 ()
  • 00816490021353 ()
HCDOAF-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-8104
In Commercial Distribution

  • 20816490021210 ()
  • 10816490021213 ()
  • 00816490021216 ()
HCDOAF-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOA-1104S
In Commercial Distribution

  • 20816490021197 ()
  • 10816490021190 ()
  • 00816490021193 ()
HCDOA-1104S

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOA-855
In Commercial Distribution

  • 20816490021142 ()
  • 10816490021145 ()
  • 00816490021148 ()
HCDOA-855

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup ;
Healgen Scientific Limited Liability Company
HCDOA-955
In Commercial Distribution

  • 20816490021074 ()
  • 10816490021077 ()
  • 00816490021070 ()
HCDOA-955

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-2104
In Commercial Distribution

  • 20816490020701 ()
  • 10816490020704 ()
  • 00816490020707 ()
HCDOAF-2104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Alere Triage® Profiler SOB™ Panel
ALERE SAN DIEGO, INC.
97300EU
Not in Commercial Distribution

  • 00899722002740 ()
97300EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
1 Panel Home Drug Test Kit THC
CONFIRM BIOSCIENCES, INC.
RO-DRC001
In Commercial Distribution

  • 00895330002356 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
ECLIPSE WIDE BACK PANEL VQ PALE BLUE
Vision Quest Industries Incorporated
40-10000-030
In Commercial Distribution

  • 00817717020333 ()


  • Cervical spine collar, reusable
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