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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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Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
11x4 ml
In Commercial Distribution

  • 07640137341749 ()
213231

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use.
Medion Grifols Diagnostics AG
11x4 ml
In Commercial Distribution

  • 07640137341459 ()
213641

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. Data-Cyte Extend 0.8% cannot detect anti-D. For in vitro diagnotic use.
Medion Grifols Diagnostics AG
4 x 4ml
In Commercial Distribution

  • 07640137341442 ()
213684

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use.
Medion Grifols Diagnostics AG
11x4 ml
In Commercial Distribution

  • 07640137340285 ()
213654

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
11x4 ml
Not in Commercial Distribution

  • 07640137340278 ()
213392

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC LESS HP TUBING & HOLDER BAR
Ls Enterprises, Inc.
2521MCC
In Commercial Distribution

  • D0692521MCC0 ()


  • Dental delivery system
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & UNDER WORKSURFACE PANEL CONTROL
Ls Enterprises, Inc.
2186BC
In Commercial Distribution

  • D0692186BC0 ()


  • Dental delivery system
REAR MOUNT LAMINATE WORKSURFACE & WALL MOUNT PANEL SIDE DELIVERY, DESIGNER FRIENDLY (UPCHARGE APPLIES)
Ls Enterprises, Inc.
3386WM-C
In Commercial Distribution

  • D0693386WMC0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC LESS HP TUBING & HOLDER BAR
Ls Enterprises, Inc.
2521MCC-G
In Commercial Distribution

  • D0692521MCCG0 ()


  • Dental delivery system
BlueRapids CLIA Waived Drug Cup; 6 Panel AMP/BZO/COC/MET/OPI2000/THC
MERCEDES MEDICAL, LLC
TNR CDOA261
In Commercial Distribution

  • 20850011007031 ()
  • 10850011007034 ()
  • 00850011007037 ()
TNR CDOA261

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
TMK-IFAK Insert is a low-profile medical panel outfitted with critical lifesaving medical supplies.
Altitude Technologies Inc.
01237REF
In Commercial Distribution

  • 00850018892520 ()
01237REF

  • First aid kit, non-medicated, single-use
TMK-IFAK Insert is a low-profile medical panel outfitted with critical lifesaving medical supplies.
Altitude Technologies Inc.
01237CB
In Commercial Distribution

  • 00850018892513 ()
01237CB

  • First aid kit, non-medicated, single-use
TMK-IFAK Insert is a low-profile medical panel outfitted with critical lifesaving medical supplies.
Altitude Technologies Inc.
01237BK
In Commercial Distribution

  • 00850018892506 ()
01237BK

  • First aid kit, non-medicated, single-use
A grid for 17" x 17" flat panel sensor mounted onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 GRID4343 E
In Commercial Distribution

  • 04547410467888 ()

  • 453 mm x 453 mm x 1.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
A grid for 14" x 17" flat panel sensor mounted onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 GRID3543 E
In Commercial Distribution

  • 04547410467871 ()

  • 377 mm x 453 mm x 1.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
A grid for 10" x 12" flat panel sensor mounted onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 GRID2530 E
In Commercial Distribution

  • 04547410467857 ()

  • 275 mm x 349 mm x 1.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
7-Drug Test Panel - 25/Kit (7.17) - COC300 MET1000 MOP300 OPI2000 OXY100 BZO300 BUP10
BTNX Inc
D7.17-1P29-25
In Commercial Distribution

  • 00722066004791 ()
  • 00722066004807 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Touch Panel Control M-Series is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995165505 ()
10060498

  • Medical monitor/light mount
14 Panel urine cup that tests for (THC-COC150-MOP-AMP500-MET500-PCP-BZO-BAR-MDMA-MTD-OXY-BUP-TCA-EDDP) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALL8145R
In Commercial Distribution

  • 00861272000385 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel urine cup that tests for (THC-COC-OPI-AMP-MET) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALL254R
In Commercial Distribution

  • 00861272000378 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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