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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 - 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 - 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 - 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 - 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

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 - 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 - 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

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 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 32:1 - ENOU5054NOU0

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

  • ENOU5054NOU0 ()


  • 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

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

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

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

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

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

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

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

TITAN IMPLANTS, INC. - 00842448114457

4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG14S2
In Commercial Distribution

  • 00842448114457 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114433

4.8mm Diameter, 6.5mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG12S2
In Commercial Distribution

  • 00842448114433 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114419

4.8mm Diameter, 6.5mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG10S2
In Commercial Distribution

  • 00842448114419 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114365

4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/6TG14R1
In Commercial Distribution

  • 00842448114365 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114310

4.8mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG14S2
In Commercial Distribution

  • 00842448114310 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114297

4.8mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG12S2
In Commercial Distribution

  • 00842448114297 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114273

4.8mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG10S2
In Commercial Distribution

  • 00842448114273 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114259

4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG8S2
In Commercial Distribution

  • 00842448114259 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114228

4.8mm Diameter, 4.8mm Platform TG Implant Length 14.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG14R1
In Commercial Distribution

  • 00842448114228 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114198

4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10S1
In Commercial Distribution

  • 00842448114198 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114181

4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10R1
In Commercial Distribution

  • 00842448114181 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114167

4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG8R1
In Commercial Distribution

  • 00842448114167 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114150

4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG14S2
In Commercial Distribution

  • 00842448114150 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114136

4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG12S2
In Commercial Distribution

  • 00842448114136 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114112

4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG10S2
In Commercial Distribution

  • 00842448114112 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114068

4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG14R1
In Commercial Distribution

  • 00842448114068 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114051

4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12S1
In Commercial Distribution

  • 00842448114051 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114044

4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12R1
In Commercial Distribution

  • 00842448114044 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114037

4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG10S1
In Commercial Distribution

  • 00842448114037 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114006

4.1mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG8R1
In Commercial Distribution

  • 00842448114006 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448113993

3.3mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG14S1
In Commercial Distribution

  • 00842448113993 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448113986

3.3mm Diameter, 4.8mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG14R1
In Commercial Distribution

  • 00842448113986 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448113979

3.3mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG12S1
In Commercial Distribution

  • 00842448113979 ()


  • Dental implant system
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