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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AMD-RITMED COUNTWAY SYSTEM PANEL WITH POCKETS
AMD Medicom Inc
2213-BL
In Commercial Distribution

  • 20686864048033 ()
  • 10686864048036 ()
  • 00686864048039 ()
2213-BL

  • Surgical sponge-counting tray
AMD-RITMED COUNTWAY SYSTEM PANEL WITH POCKETS
AMD Medicom Inc
2213
In Commercial Distribution

  • 20686864048026 ()
  • 10686864048029 ()
  • 00686864048022 ()
2213

  • Surgical sponge-counting tray
2 panel InCup w/THC & Meth
AMERICAN BIO MEDICA CORPORATION
10-2MC-000
In Commercial Distribution

  • 10694644400141 ()
  • 10694644450146 ()
10-2MC-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 Panel with BZO, 300ng OPI
AMERICAN BIO MEDICA CORPORATION
10-5Z1-030
In Commercial Distribution

  • 10694644300458 ()
  • 10694644350453 ()
10-5Z1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 PANEL W/METH,OXY, OPI300
AMERICAN BIO MEDICA CORPORATION
10-5MO1-030
In Commercial Distribution

  • 10694644300281 ()
  • 10694644350286 ()
10-5MO1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 panel w/Coc & Meth Single
AMERICAN BIO MEDICA CORPORATION
10-2CM1-000
In Commercial Distribution

  • 10694644300083 ()
  • 10694644350088 ()
10-2CM1-000

  • Oxycodone IVD, calibrator
10 panel RAPIDTOX CUP II: AMP
AMERICAN BIO MEDICA CORPORATION
10-10XX2AB-030
In Commercial Distribution

  • 10694644200369 ()
  • 10694644250364 ()
10-10XX2AB-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 Panel Rapid Tox opi 2000
AMERICAN BIO MEDICA CORPORATION
10-10XT-200
In Commercial Distribution

  • 10694644100041 ()
  • 10694644150046 ()
10-10XT-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 Panel Rapid Tox opi 300
AMERICAN BIO MEDICA CORPORATION
10-10XT-030
In Commercial Distribution

  • 10694644100034 ()
  • 10694644150039 ()
10-10XT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
BIPOLAR SOCKET, NEW STYLE PANEL MOUNTED
ELMED INCORPORATED
5-001
In Commercial Distribution

  • 00198506074097 ()
5-001

  • Electrosurgical cable adaptor
PANEL 04 COC150/AMP1000/THC/MOP300
REDWOOD TOXICOLOGY LABORATORY, INC.
011020199
In Commercial Distribution

  • 10858904006584 ()
  • 00858904006587 ()
DOA-144-1041

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 04 COC150/ THC/MOP300/MAMP500
REDWOOD TOXICOLOGY LABORATORY, INC.
011020195
In Commercial Distribution

  • 10858904006577 ()
  • 00858904006570 ()
DOA-144-621

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 4 COC/M-AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020012
In Commercial Distribution

  • 10858904006225 ()
  • 00858904006228 ()
DOA-344-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC
In Commercial Distribution

  • 20850721007369 ()
  • 10850721007362 ()
  • 00850721007365 ()
ID-THC

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
U-THC-114
In Commercial Distribution

  • 10850721007027 ()
  • 00850721007020 ()
  • 20850721007024 ()
U-THC-114

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
PANEL 4 COC/AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020032
In Commercial Distribution

  • 10858904006232 ()
  • 00858904006235 ()
DOA-844-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Visual-ICE™ MRI Mobile Connection Panel
BOSTON SCIENTIFIC CORPORATION
H7493970071000
In Commercial Distribution

H7493970071000

  • General cryosurgical system, cryogen gas, electronic
KIT, DOOR PANEL w' QUIKCLOT - BLK
NORTH AMERICAN RESCUE, LLC
80-1167
In Commercial Distribution

  • 00842209119004 ()
80-1167

  • First aid kit, medicated
KIT, TORK w' DETACH PANEL - BLK
NORTH AMERICAN RESCUE, LLC
85-1946
In Commercial Distribution

  • 00842209106899 ()
85-1946

  • First aid kit, non-medicated, single-use
Negative quality control for T2Biothreat Panel
T2 BIOSYSTEMS, INC.
85-11398
In Commercial Distribution

  • M70883113970 ()
  • M70885113983 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
Kit BD MAX Enteric Viral Panel
BECTON, DICKINSON AND COMPANY
443985
In Commercial Distribution

  • 00382904439859 ()
443985

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Bacterial Panel
BECTON, DICKINSON AND COMPANY
442963
In Commercial Distribution

  • 00382904429638 ()
442963

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Parasite Panel
BECTON, DICKINSON AND COMPANY
442960
In Commercial Distribution

  • 00382904429607 ()
442960

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
24" UNIVERSAL 3 PANEL KNEE IMMOBILIZER
TETRA MEDICAL SUPPLY CORP.
282400
In Commercial Distribution

  • 00614138114302 ()
282400

  • Knee immobilizer
20" UNIVERSAL 3 PANEL KNEE IMMOBILIZER
TETRA MEDICAL SUPPLY CORP.
282000
In Commercial Distribution

  • 00614138114289 ()
282000

  • Knee immobilizer
16" UNIVERSAL 3 PANEL KNEE IMMOBILIZER
TETRA MEDICAL SUPPLY CORP.
281600
In Commercial Distribution

  • 00614138114272 ()
281600

  • Knee immobilizer
12IN UNIVERSAL 3 PANEL KNEE IMMOBILIZER
TETRA MEDICAL SUPPLY CORP.
2812-00
In Commercial Distribution

  • 00614138114258 ()
2812-00

  • Knee immobilizer
22IN UNIVERSAL 3 PANEL KNEE IMMOBILIZER
TETRA MEDICAL SUPPLY CORP.
282200
In Commercial Distribution

  • 00614138101203 ()
282200

  • Knee immobilizer
Ab Binder, Extra Large (4 Panel)
PEPPER MEDICAL INC.
AB475
In Commercial Distribution

  • 00850014574598 ()
AB475

  • Abdominal binder, single-use
Specialty Diagnostix Panel 2, 2x5mL Kitbox
BIOCHEMICAL DIAGNOSTICS INC
18007751
In Commercial Distribution

  • 00850004812099 ()
18007751

  • Multiple drugs of abuse IVD, control
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