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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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STAT PROFILE - 00385480489041

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 9/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489041 ()
48904

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480451505

Prime Auto QC Cartridge CCS 200 Sample
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480451505 ()
45150

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480341172

STAT PROFILE pHOx PLUS L CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus L
In Commercial Distribution

  • 00385480341172 ()
  • 00385489341173 ()
34117

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340922

Stat Profile pHOx Plus L Controls Auto-Cartridge, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340922 ()
34092

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306447

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306447 ()
30644

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480278966

STAT PROFILE pHOx PLUS/C CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus/c
In Commercial Distribution

  • 00385480278966 ()
  • 00385489278967 ()
27896

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239318

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,110
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239318 ()
23931

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480489355

Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480489034

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 6/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489034 ()
48903

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480356381

STAT PROFILE CRITICAL CARE XPRESS CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution

  • 00385480356381 ()
  • 00385489356382 ()
35638

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340939

Stat Profile pHOx Plus L Controls Auto-Cartridge, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340939 ()
34093

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340915

Stat Profile pHOx Plus L Controls Auto-Cartridge, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340915 ()
34091

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340908

Stat Profile pHOx Plus L Controls Auto-Cartridge, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340908 ()
34090

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306461

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306461 ()
30646

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306454

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306454 ()
30645

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306430

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306430 ()
30643

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239332

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,330
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239332 ()
23933

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239325

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,220
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239325 ()
23932

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239301

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,75
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239301 ()
23930

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480227636

STAT PROFILE pHOx/BASIC CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox/basic
In Commercial Distribution

  • 00385480227636 ()
  • 00385489227637 ()
22763

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Contra Angle 70:1 - ENOU5065NOU0

Contra Angle 70:1
Nouvag AG
5065NOU
In Commercial Distribution

  • ENOU5065NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 16:1 Endodontics - ENOU5061NOU0

Contra Angle 16:1 Endodontics
Nouvag AG
5061NOU
In Commercial Distribution

  • ENOU5061NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 32:1 - ENOU5054NOU0

Contra Angle 32:1
Nouvag AG
5054NOU
In Commercial Distribution

  • ENOU5054NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 1:1 - ENOU5051NOU0

Contra Angle 1:1
Nouvag AG
5051NOU
In Commercial Distribution

  • ENOU5051NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 1:1 - ENOU5050NOU0

Contra Angle 1:1
Nouvag AG
5050NOU
In Commercial Distribution

  • ENOU5050NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Clip for Contra Angle - ENOU18819

Clip for Contra Angle
Nouvag AG
1881
In Commercial Distribution

  • ENOU18819 ()
  • ENOU18810 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 8:1 Endodontics - ENOU5057NOU0

Contra Angle 8:1 Endodontics
Nouvag AG
5057NOU
In Commercial Distribution

  • ENOU5057NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 20:1 LED - ENOU5052NOU0

Contra Angle 20:1 LED
Nouvag AG
5052nou
In Commercial Distribution

  • ENOU5052NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Coulmed - 10810087350106

Covex Sterile X-Ray Cassette Cover: 24" x 24"
Coulmed Products Group LLC
DI-5503
In Commercial Distribution

  • 30810087350100 ()
  • 10810087350106 ()
DI-5503

  • Medical equipment/instrument drape, single-use

Perma Pure - 00840106901784

24" DRYER, MED. GRAPHICS 24" DRYER, MED. GRAPHICS
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 00840106901821 ()
  • 00840106901784 ()
  • 00840106901814 ()
  • 00840106901807 ()
  • 00840106901791 ()
ME-050-03-99

  • Gas-sampling/monitoring respiratory tubing, single-use

Encompass - 00609953925981

24 X 24 2 PLY DRAPE T180 MIST
Encompass Group, L.L.C.
CD0033
In Commercial Distribution

  • 50609953925986 ()
  • 00609953925981 ()


  • Patient surgical drape, reusable

Tissue-Tek® - 00615233078100

Base Mold 24 x 24 x 5 mm
SAKURA FINETEK U.S.A., INC.
4163
In Commercial Distribution

  • 00615233078100 ()
4163

  • Tissue embedding mould IVD, reusable

Hu-Friedy - 10889950002732

IMS STERILIZATION WRAP 24 x 24 100 SHEET
HU-FRIEDY MFG. CO., LLC
IMS-1210H
In Commercial Distribution

  • 10889950002732 ()
  • 10889950075033 ()
IMS-1210H

  • Sterilization packaging, single-use

Therapak - 07312058462673

Therapak Acetic Acid 24 Hour Collection (CS/24)
Therapak LLC
ACSK38533
In Commercial Distribution

  • 07312058462673 ()
ACSK38533

  • 24-hour urine specimen container IVD, preservative

OPTICS ONE - 00815384022346

X-ray Cassette Cover 24 x 24 Adhesive Closure
MEDICAL TECHNIQUE, INC.
9954-50
In Commercial Distribution

  • 00815384022360 ()
  • 00815384022353 ()
  • 00815384022346 ()
9954-50

  • Instrument/equipment drape, single-use, sterile

BLOXR - 10811042030583

XPF® Patient Protection Shield, 24" x 24"
BLOXR Solutions, LLC
100210
In Commercial Distribution

  • 10811042030583 ()


  • Radiation shielding apron

BluEX Lumbar Expandable Cage System - 08809986465870

BluEX-A (24 X 32 X 24 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-2425S
In Commercial Distribution

  • 08809986465870 ()


  • Metallic spinal interbody fusion cage

Saw Disk - 08800053005043

Dental Implant Instrument / Saw Disk
DENTIS CO. ,LTD
DSDSAW-09
In Commercial Distribution

  • 08800053005043 ()


  • Surgical power tool system handpiece, sawing, line-powered

DYONICS POWER - 03596010410733

DYONICS POWER SAGITTAL SAW ATTACHMENT
Smith & Nephew, Inc.
7205791
In Commercial Distribution

  • 03596010410733 ()
7205791

  • Surgical power tool system handpiece, sawing, line-powered

DYONICS POWER - 03596010410719

DYONICS POWER SAGITTAL SAW
Smith & Nephew, Inc.
7205786
In Commercial Distribution

  • 03596010410719 ()
7205786

  • Surgical power tool system handpiece, sawing, line-powered
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