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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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Preat - 00842092183038

ASC NobelActive™/Conical-compatible 3.0mm Titanium Blank
Preat Corporation
9004765
In Commercial Distribution

  • 00842092183038 ()
9004765

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092183021

ASC MegaGen AnyRidge®-compatible RP Titanium Blank
Preat Corporation
9004465
In Commercial Distribution

  • 00842092183021 ()
9004465

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092183014

ASC Neoss®-compatible 3.5-6.0 mm Titanium Blank
Preat Corporation
9004165
In Commercial Distribution

  • 00842092183014 ()
9004165

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092183007

ASC Astra®-compatible Lilac 4.5/5.0 mm Titanium Blank
Preat Corporation
9002265
In Commercial Distribution

  • 00842092183007 ()
9002265

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182994

ASC Astra®-compatible Aqua 3.5/4.0 mm Titanium Blank
Preat Corporation
9002165
In Commercial Distribution

  • 00842092182994 ()
9002165

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182987

ASC Astra®-compatible 3.0mm Titanium Blank
Preat Corporation
9002065
In Commercial Distribution

  • 00842092182987 ()
9002065

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182970

ASC Biomet 3i Certain®-compatible 6.0 mm Titanium Blank
Preat Corporation
9001965
In Commercial Distribution

  • 00842092182970 ()
9001965

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182963

ASC Biomet 3i Certain®-compatible 5.0 mm Titanium Blank
Preat Corporation
9001865
In Commercial Distribution

  • 00842092182963 ()
9001865

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182956

ASC Biomet 3i Certain®-compatible 4.1 mm Titanium Blank
Preat Corporation
9001765
In Commercial Distribution

  • 00842092182956 ()
9001765

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182949

ASC Biomet 3i Certain®-compatible 3.4 mm Titanium Blank
Preat Corporation
9001665
In Commercial Distribution

  • 00842092182949 ()
9001665

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182932

ASC Straumann Bone Level NC-Compatible Titanium Blank
Preat Corporation
9001565
In Commercial Distribution

  • 00842092182932 ()
9001565

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182925

ASC Straumann® BL-compatible RC Titanium Blank
Preat Corporation
9001465
In Commercial Distribution

  • 00842092182925 ()
9001465

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182918

ASC Straumann® TL-compatible RN Titanium Blank
Preat Corporation
9001265
In Commercial Distribution

  • 00842092182918 ()
9001265

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182901

ASC NobelActive™/Conical-compatible RP Titanium Blank
Preat Corporation
9000965
In Commercial Distribution

  • 00842092182901 ()
9000965

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182895

ASC NobelActive™/Conical-compatible NP Titanium Blank
Preat Corporation
9000865
In Commercial Distribution

  • 00842092182895 ()
9000865

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182888

ASC NobelBiocare™ Tri-Lobe-compatible 6.0 mm Titanium Blank
Preat Corporation
9000765
In Commercial Distribution

  • 00842092182888 ()
9000765

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182871

ASC NobelBiocare™ Tri-Lobe-compatible WP Titanium Blank
Preat Corporation
9000665
In Commercial Distribution

  • 00842092182871 ()
9000665

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182864

ASC NobelBiocare™ Tri-Lobe-compatible RP Titanium Blank
Preat Corporation
9000565
In Commercial Distribution

  • 00842092182864 ()
9000565

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182857

ASC NobelBiocare™ Tri-Lobe-compatible NP Titanium Blank
Preat Corporation
9000465
In Commercial Distribution

  • 00842092182857 ()
9000465

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182840

ASC Zimmer TSV 5.7mm-Compatible Titanium Blank
Preat Corporation
9000365
In Commercial Distribution

  • 00842092182840 ()
9000365

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182833

ASC Hiossen® HG-compatible Standard Titanium Blank
Preat Corporation
9005165
In Commercial Distribution

  • 00842092182833 ()
9005165

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182826

ASC Zimmer TSV 4.5mm-Compatible Titanium Blank Kit contains 1 ASC Zimmer® TSV-compatible 4.5 mm Titanium Blank and 2 ASC Zimmer® TSV-compatible 3.5mm/4.5mm/5.7mm Titanium Screws
Preat Corporation
9000265
In Commercial Distribution

  • 00842092182826 ()
  • 10842092182823 ()
9000265

  • Dental implant suprastructure, permanent, preformed

Preat - 00842092182819

ASC Zimmer® TSV-compatible 3.5mm Titanium Blank Kit contains 1 ASC Zimmer® TSV-compatible 3.5mm Titanium Blank and 2 ASC Zimmer® TSV-compatible 3.5mm/4.5mm/5.7mm Titanium Screws
Preat Corporation
9000165
In Commercial Distribution

  • 00842092182819 ()
  • 10842092182816 ()
9000165

  • Dental implant suprastructure, permanent, preformed

NA - 00841983102592

BASE UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-123A
In Commercial Distribution

  • 00841983102592 ()
QI-123A

  • Electroencephalograph

LibreView Government - 00357599826000

LibreViewGov
ABBOTT DIABETES CARE INC
72157-01
In Commercial Distribution

  • 00357599826000 ()
72157-01

  • Self-care monitoring/reporting software

LibreView - 00357599823009

LibreView
ABBOTT DIABETES CARE INC
72156-01
In Commercial Distribution

  • 00357599823009 ()
72156-01

  • Self-care monitoring/reporting software

NA - 00841983100659

Electrode junction box (256 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-24
In Commercial Distribution

  • 00841983100659 ()
JE-120A-24

  • Electroencephalograph

NA - 00841983101199

EXTENDED LAN UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-124A
In Commercial Distribution

  • 00841983101199 ()
QI-124A

  • Electroencephalograph

NA - 00841983100642

Electrode junction box (192 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-23
In Commercial Distribution

  • 00841983100642 ()
JE-120A-23

  • Electroencephalograph

NA - 00841983100635

Electrode junction box (128 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-22
In Commercial Distribution

  • 00841983100635 ()
JE-120A-22

  • Electroencephalograph

NA - 00841983100628

Electrode junction box (64 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A
In Commercial Distribution

  • 00841983100628 ()
JE-120A-21

  • Electroencephalograph

GeoSource 2.0 Source Estimation Software - 00850033571028

No Description
Magstim, Inc.
6150036
In Commercial Distribution

  • 00850033571028 ()


  • Electroencephalograph

myPKFiT for Patients Mobile Application - 00850025688826

Mobile application used by patients for disease management
Takeda Pharmaceuticals U.S.A., Inc.
V2
In Commercial Distribution

  • 00850025688826 ()


  • Home pharmaceutical management support software

myPKFiT for Healthcare Professionals - 00850025688819

Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution

  • 00850025688819 ()


  • Home pharmaceutical management support software

ELEFT (Eko Low Ejection Fraction Tool) - 00850010298146

Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution

  • 00850010298146 ()
ELEFT

  • Cardiopulmonary physiological parameter analysis software

Bigfoot Unity Report - 00850003506517

No Description
Bigfoot Biomedical, Inc.
SW-300983
In Commercial Distribution

  • 00850003506517 ()
SW-300983

  • Self-care monitoring/reporting software

Natus - 00382830022286

EP WORKS for Protektor32 DVD
XLTEK
007135
In Commercial Distribution

  • 00382830022286 ()


  • Electroencephalograph

Natus - 00382830022279

Neuroworks/Sleepworks 8.1.1 GMA3 US DVD
XLTEK
016049
In Commercial Distribution

  • 00382830022279 ()


  • Electroencephalograph

Natus - 00382830022262

Neuroworks/Sleepworks 8.1.0 GMA3 Int'l DVD
XLTEK
016048
In Commercial Distribution

  • 00382830022262 ()


  • Electroencephalograph

Natus - 00382830022255

NEUROWORKS 8.0.1 US DVD
XLTEK
013192
In Commercial Distribution

  • 00382830022255 ()


  • Electroencephalograph
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