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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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Alpha-Tec Systems - 00816085021393

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

  • 00816085021393 ()
0004621

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021386

PROTO-FIX with CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()
  • 00816085021386 ()
0004616

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021355

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

Alpha-Tec Systems - 00816085021331

PROTO-FIX/Clean Vial 25 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021447 ()
  • 00816085021331 ()
0004604

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021317

PROTO-FIX 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021423 ()
  • 00816085021317 ()
0004602

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021249

90% Acid-Ethanol 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021249 ()
0004406

  • Biological stain IVD

Alpha-Tec Systems - 00816085021195

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

  • 00816085021195 ()
0004216

  • Biological stain IVD

Alpha-Tec Systems - 00816085021171

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

  • 00816085021171 ()
0004210

  • Biological stain IVD

Alpha-Tec Systems - 00816085021157

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

  • 00816085021157 ()
0004208

  • Biological stain IVD

Alpha-Tec Systems - 00816085021065

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

  • 00816085021065 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020525

AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020143 ()
  • 00816085020525 ()
0003245

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020518

AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020136 ()
  • 00816085020518 ()
0003240

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020501

AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020136 ()
  • 00816085020501 ()
0003243

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020488

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 2" x 4" Pro Pulse HD - B243PSSA2X4PP4

Self-Adhesive Electrode
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSSA2X4PP4 ()


  • Transdermal medication patch

Self-Adhesive Electrode 2" x 2" Pro Pulse HD - B243PSSA2X2PP4

Self-Adhesive Electrode
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSSA2X2PP4 ()


  • Transcutaneous electrical stimulation electrode, single-use

Carbon-Rubber Electrodes (2" Round) - B243PSRCR552

No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
In Commercial Distribution

  • B243PSRCR552 ()


  • Transcutaneous electrical stimulation electrode, single-use

Carbon-Rubber Electrodes (8" x 3") - B243PSRCR2102

No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSRCR2102 ()


  • Transcutaneous electrical stimulation electrode, single-use

Alpha-Tec Systems - 00816085024134

Methanol, Absolute
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024134 ()
0003339

  • Biological stain IVD

Alpha-Tec Systems - 00816085024127

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

  • 00816085024127 ()
0003730

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024110

QC1 Malaria Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024103 ()
  • 00816085024110 ()
0003267

  • Biological stain control IVD

Alpha-Tec Systems - 00816085024097

NALC Diluent
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024097 ()
0004820

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024080

NALC Diluent
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024080 ()
X000489

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024073

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

Alpha-Tec Systems - 00816085024066

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

Alpha-Tec Systems - 00816085024059

NAC-PAC EA3 (3.0%) tray w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024059 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024042

NAC-PAC EA3 (2.5%) tray w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024042 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024035

0.9% Saline 4.0ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024035 ()
0003516

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024028

0.9% Saline 4.5ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024028 ()
0003520

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024011

0.9% Saline 5.0ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024011 ()
0003521

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023861

Bovine Albumin Fraction V 10x10ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023861 ()
0003470

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023847

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

Alpha-Tec Systems - 00816085023830

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

Alpha-Tec Systems - 00816085023823

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

Alpha-Tec Systems - 00816085023809

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

Alpha-Tec Systems - 00816085023793

Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023793 ()
0003358

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023786

Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023786 ()
X000401

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023779

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

SAMPEDRO - 07708626670418

Depth Gauge 110 mm
INDUSTRIAS MEDICAS SAMPEDRO S A S
0
In Commercial Distribution

  • 07708626670418 ()
/MP110-W3

  • Surgical depth gauge, reusable

SAMPEDRO - 07708626670388

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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