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

  • 00816085020303 ()
  • 00816085020310 ()
0003265

  • Biological stain control IVD
Mycology Quality Control Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020303 ()
0003265S

  • Biological stain control IVD
Trichomonas Quality Control Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020280 ()
  • 00816085020297 ()
0003268

  • Biological stain control IVD
NAC-PAC N30 Tray
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020273 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (3.0%), 50mL
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020266 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NPC-67 Neutralizing Buffer, 250mL bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020259 ()


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

  • 00816085020181 ()
0003255S

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

  • 00816085020167 ()
0003248S

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

  • B666MCGK60620 ()
MCGK6-062

  • Orthopaedic bone pin, non-bioabsorbable
K-WIRE .062 (1.6MM) X 4" LG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGK40620 ()
MCGK4-062

  • Orthopaedic bone pin, non-bioabsorbable
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Workstation
In Commercial Distribution

  • 00840682100038 ()
H5014WS

  • Breast ultrasound imaging system
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS System
Not in Commercial Distribution

  • 00840682100014 ()
H5014PM

  • Breast ultrasound imaging system
Nova Max Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480458242 ()
  • 00385480458245 ()
  • 20385480458249 ()
45824

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
StatStrip Xpress Glucose Meter and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
Xpress
In Commercial Distribution

  • 10385480434048 ()
  • 00385480434041 ()
43404

  • Glucose monitoring system IVD, point-of-care
StatStrip Glucose Meter With Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480449936 ()
  • 00385480449939 ()
44993

  • Glucose monitoring system IVD, point-of-care
Nova Max Link with Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
Link
In Commercial Distribution

  • 10385480445853 ()
  • 00385480445856 ()
  • 20385480445850 ()
44585

  • Glucose monitoring system IVD, home-use
Nova Max Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480434369 ()
  • 00385480434362 ()
  • 20385480434366 ()
43436

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
Nova Max Plus Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480434352 ()
  • 00385480434355 ()
  • 20385480434359 ()
43435

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
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