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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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PROTO-FIX 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021393 ()
0004621

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX with CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()
  • 00816085021386 ()
0004616

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX [2 Vials] /Clean Vial 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021461 ()
  • 00816085021355 ()
0004606C

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX/Clean Vial 25 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021447 ()
  • 00816085021331 ()
0004604

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021423 ()
  • 00816085021317 ()
0004602

  • Sputum specimen liquefaction/decontamination kit IVD
90% Acid-Ethanol 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021249 ()
0004406

  • Biological stain IVD
70% Ethanol 3.875L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021195 ()
0004216

  • Biological stain IVD
90% Ethanol 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021171 ()
0004210

  • Biological stain IVD
Methylene Blue Phosphate Pre-Stain 250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021157 ()
0004208

  • Biological stain IVD
NAC-PAC RED (3.0%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021065 ()


  • Sputum specimen liquefaction/decontamination kit IVD
AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020143 ()
  • 00816085020525 ()
0003245

  • Biological stain control IVD
AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020136 ()
  • 00816085020518 ()
0003240

  • Biological stain control IVD
AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020136 ()
  • 00816085020501 ()
0003243

  • Biological stain control IVD
Gram Stain Control Slides With 3 Patient Wells
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020112 ()
  • 00816085020488 ()
0003235

  • Biological stain control IVD
Self-Adhesive Electrode
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSSA2X4PP4 ()


  • Transdermal medication patch
Self-Adhesive Electrode
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSSA2X2PP4 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
In Commercial Distribution

  • B243PSRCR552 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSRCR2102 ()


  • Transcutaneous electrical stimulation electrode, single-use
Methanol, Absolute
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024134 ()
0003339

  • Biological stain IVD
VTM Viral Transport Medium Pack
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024127 ()
0003730

  • Sputum specimen liquefaction/decontamination kit IVD
QC1 Malaria Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024103 ()
  • 00816085024110 ()
0003267

  • Biological stain control IVD
NALC Diluent
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024097 ()
0004820

  • Sputum specimen liquefaction/decontamination kit IVD
NALC Diluent
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024080 ()
X000489

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (3.0%) w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024059 ()
  • 00816085024073 ()
0004813

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (2.5%) w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024042 ()
  • 00816085024066 ()
0004819

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (3.0%) tray w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024059 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (2.5%) tray w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024042 ()


  • Sputum specimen liquefaction/decontamination kit IVD
0.9% Saline 4.0ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024035 ()
0003516

  • Sputum specimen liquefaction/decontamination kit IVD
0.9% Saline 4.5ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024028 ()
0003520

  • Sputum specimen liquefaction/decontamination kit IVD
0.9% Saline 5.0ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024011 ()
0003521

  • Sputum specimen liquefaction/decontamination kit IVD
Bovine Albumin Fraction V 10x10ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023861 ()
0003470

  • Sputum specimen liquefaction/decontamination kit IVD
Centrifuge Tubes, 50 mL, 20 Bags x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023847 ()
0001352

  • Faecal parasite specimen concentration kit IVD
Centrifuge Tubes, 15 mL, 20 Bags x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023830 ()
0001518

  • Faecal parasite specimen concentration kit IVD
Centrifuge Tubes, 15 mL, 20 Trays x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023823 ()
0001516

  • Faecal parasite specimen concentration kit IVD
Centrifuge Tubes, 50 mL, 20 Bags x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023809 ()
0001350

  • Faecal parasite specimen concentration kit IVD
Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023793 ()
0003358

  • Faecal parasite specimen concentration kit IVD
Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023786 ()
X000401

  • Faecal parasite specimen concentration kit IVD
PRS Parasite Recovery System (Funnel, Triton X, 15 mL Centrifuge Tube, Cap)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023779 ()
0004045

  • Faecal parasite specimen concentration kit IVD
Depth Gauge 110 mm
INDUSTRIAS MEDICAS SAMPEDRO S A S
0
In Commercial Distribution

  • 07708626670418 ()
/MP110-W3

  • Surgical depth gauge, reusable
3.5mm Self-Tapping Cortex Screws, TI, 70mm
INDUSTRIAS MEDICAS SAMPEDRO S A S
0
In Commercial Distribution

  • 07708626670388 ()
TCIAT3570

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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