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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 - 00816085020600

CELL-BOND Slides, 3 black wells
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023885 ()
  • 00816085020600 ()
0003258

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020594

CELL-BOND Slides, no wells or background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023892 ()
  • 00816085020594 ()
0003257

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020587

Cryptosporidium QC Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020198 ()
  • 00816085020587 ()
0003256

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020570

PROTO-FIX QC Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020181 ()
  • 00816085020570 ()
0003255

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020563

Zn PVA QC Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020174 ()
  • 00816085020563 ()
0003251

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020556

Zn PVA QC Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020174 ()
  • 00816085020556 ()
0003254

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020549

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

  • 00816085020167 ()
  • 00816085020549 ()
0003248

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020532

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

  • 00816085020150 ()
  • 00816085020532 ()
0003247

  • Biological stain control 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 - 00816085020495

Gram Stain Control Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020129 ()
  • 00816085020495 ()
0003238

  • 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

Alpha-Tec Systems - 00816085020471

Gram Stain Control Slides With 3 Patient Wells
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020112 ()
  • 00816085020471 ()
0003236

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020464

Gram Stain QC Slides with one specimen well
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020099 ()
  • 00816085020464 ()
0003231

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020457

Gram Stain QC Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020082 ()
  • 00816085020457 ()
0003230

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020440

Gram Stain QC Slides (10 Pk)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020082 ()
  • 00816085020440 ()
0003233

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020433

CELL-BOND Slides, 2 wells [15mm], red background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023908 ()
  • 00816085020433 ()
0003222

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020426

CELL-BOND Slides, 2 Wells, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023915 ()
  • 00816085020426 ()
0003221

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020419

CELL-BOND Slides, 1 Well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023922 ()
  • 00816085020419 ()
0003220

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020402

CELL-BOND Slides, 1 Well, blue background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023939 ()
  • 00816085020402 ()
0003219

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020396

CELL-BOND Slides, 2 Red Wells
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023946 ()
  • 00816085020396 ()
0003218

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020389

CELL-BOND Slides, 1 Well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023953 ()
  • 00816085020389 ()
0003217

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020372

CELL-BOND Slides, 1 Well, white background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023960 ()
  • 00816085020372 ()
0003215

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020365

NPC-67 Neutralizing Buffer, 8x250mL
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020365 ()
0003941

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020358

CELL-BOND Slides, 1 well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023977 ()
  • 00816085020358 ()
0003216

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020341

CELL-BOND Slides, 1 well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023984 ()
  • 00816085020341 ()
0003224

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020334

CELL-BOND Slides, 1 well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020334 ()
S003224

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020310

Mycology Quality Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020303 ()
  • 00816085020310 ()
0003265

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020303

Mycology Quality Control Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020303 ()
0003265S

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020297

Trichomonas Quality Control Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020280 ()
  • 00816085020297 ()
0003268

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020273

NAC-PAC N30 Tray
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020273 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020266

NAC-PAC RED (3.0%), 50mL
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020266 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020259

NPC-67 Neutralizing Buffer, 250mL bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020259 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020181

PROTO-FIX QC Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020181 ()
0003255S

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020167

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

  • 00816085020167 ()
0003248S

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020105

CELL-BOND Slide, 1 Red well, no background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020105 ()
S003223

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020075

CELL-BOND Slides, 2 wells [15mm], red background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020075 ()
S003222

  • General specimen microscopy slide IVD, single-use

Lever Action Plate System - B666MCGK60620

K-WIRE .062 (1.6MM) X 6" LG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGK60620 ()
MCGK6-062

  • Orthopaedic bone pin, non-bioabsorbable

Lever Action Plate System - B666MCGK40620

K-WIRE .062 (1.6MM) X 4" LG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGK40620 ()
MCGK4-062

  • Orthopaedic bone pin, non-bioabsorbable
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