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 05 COC150/MAMP500/THC/OPI/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020196
In Commercial Distribution

  • 10858904006591 ()
  • 00858904006594 ()
DOA-154-1791

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
HD Digital Flat Panel Color Monitor, 23"
Avalign Technologies, Inc.
72-5180023
In Commercial Distribution

  • 00190776300388 ()


  • Image display unit, colour
Fiber Optic Light Panel 4 inches 10.2CM
STERIS CORPORATION
88-1006K
In Commercial Distribution

  • 20885403285377 ()
  • 10885403285370 ()
881006K

  • Open surgical site internal light
Fiber Optic Light Panel 6 inches 15.2CM
STERIS CORPORATION
88-1004K
In Commercial Distribution

  • 20885403285353 ()
  • 10885403285356 ()
881004K

  • Open surgical site internal light
Fiber Optic Light Panel 5 inches 12.7CM
STERIS CORPORATION
88-1005K
In Commercial Distribution

  • 20885403285360 ()
  • 10885403285363 ()
881005K

  • Open surgical site internal light
Visual-ICE™ MRI Mobile Connection Panel Spare
BOSTON SCIENTIFIC CORPORATION
H74939700S71000
In Commercial Distribution

  • 00191506039752 ()
H74939700S71000

  • General cryosurgical system, cryogen gas, electronic
PANEL 5 COC/AMP/THC/OPI2/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020047
In Commercial Distribution

  • 10858904006287 ()
  • 00858904006280 ()
DOA-154-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/AMP/THC/OPI/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020033
In Commercial Distribution

  • 10858904006270 ()
  • 00858904006273 ()
DOA-1154-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/M-AMP/THC/OPI/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020013
In Commercial Distribution

  • 10858904006263 ()
  • 00858904006266 ()
DOA-554-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/AMP/M-AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020034
In Commercial Distribution

  • 10858904006256 ()
  • 00858904006259 ()
DOA-454-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/M-AMP/THC/OPI/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020015
In Commercial Distribution

  • 10858904006249 ()
  • 00858904006242 ()
DOA-654-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card BZO Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BZO-114L
In Commercial Distribution

  • 20817038021402 ()
  • 10817038021405 ()
  • 00817038021408 ()
U-BZO-114L

  • Benzodiazepine group IVD, kit, rapid ICT, clinical
u-Card BAR Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BAR-114L
In Commercial Distribution

  • 20817038021396 ()
  • 10817038021399 ()
  • 00817038021392 ()
U-BAR-114L

  • Barbiturate IVD, kit, rapid ICT, clinical
u-Card MDMA Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MDMA-114L
In Commercial Distribution

  • 20817038021389 ()
  • 10817038021382 ()
  • 00817038021385 ()
U-MDMA-114L

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
u-Card COC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-COC-114L
In Commercial Distribution

  • 10817038021375 ()
  • 00817038021378 ()
  • 20817038021372 ()
U-COC-114L

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
OPI 2000 Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OPI-114
In Commercial Distribution

  • 20817038020474 ()
  • 10817038020477 ()
  • 00817038020470 ()
U-OPI-114

  • Opiate/opiate 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
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
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
830 Single Panel Knee Immobilizer 24" (XL)
VIVE HEALTH LLC
SUP3019BLK24XL
In Commercial Distribution

  • 10810113570966 ()
  • 00810113570969 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer 20" (XL)
VIVE HEALTH LLC
SUP3019BLK20XL
In Commercial Distribution

  • 10810113570942 ()
  • 00810113570945 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer 18" (XL)
VIVE HEALTH LLC
SUP3019BLK18XL
In Commercial Distribution

  • 10810113570935 ()
  • 00810113570938 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer (XL) 16"
VIVE HEALTH LLC
SUP3019BLK16XL
In Commercial Distribution

  • 10810113570928 ()
  • 00810113570921 ()


  • Knee support orthosis
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