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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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No Description
Jiangxi Hongda Medical Equipment Group Ltd.
60mL LS
In Commercial Distribution

  • 16920756728441 ()
  • 06920756728444 ()
  • 26920756728448 ()


  • General-purpose syringe/needle
No Description
Jiangxi Hongda Medical Equipment Group Ltd.
1mL LL
In Commercial Distribution

  • 16920756728434 ()
  • 06920756728437 ()
  • 26920756728431 ()


  • General-purpose syringe/needle
No Description
Jiangxi Hongda Medical Equipment Group Ltd.
3mL LL
In Commercial Distribution

  • 16920756728427 ()
  • 06920756728420 ()
  • 26920756728424 ()


  • General-purpose syringe/needle
No Description
Jiangxi Hongda Medical Equipment Group Ltd.
5mL LL
In Commercial Distribution

  • 16920756728410 ()
  • 06920756728413 ()
  • 26920756728417 ()


  • General-purpose syringe/needle
No Description
Jiangxi Hongda Medical Equipment Group Ltd.
10mL LL
In Commercial Distribution

  • 16920756728403 ()
  • 06920756728406 ()
  • 26920756728400 ()


  • General-purpose syringe/needle
No Description
Jiangxi Hongda Medical Equipment Group Ltd.
20mL LL
In Commercial Distribution

  • 16920756728397 ()
  • 06920756728390 ()
  • 26920756728394 ()
  • 36920756728391 ()
  • 46920756728398 ()


  • General-purpose syringe/needle
No Description
Jiangxi Hongda Medical Equipment Group Ltd.
60mL LL
In Commercial Distribution

  • 16920756728380 ()
  • 06920756728383 ()
  • 26920756728387 ()


  • General-purpose syringe/needle
Femoral Stem Impactor with Anteversion
TOTAL JOINT ORTHOPEDICS, INC.
1307.00.000
In Commercial Distribution

  • 00819251021197 ()


  • Orthopaedic implant impactor, reusable
Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring
PROSOMNUS SLEEP TECHNOLOGIES
IA Monogram Monitor
In Commercial Distribution

  • 00863039000430 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery. Also available with applicator.
TOOLS FOR SURGERY, LLC
HOP-AP
In Commercial Distribution

  • 00861838000316 ()

  • Length: 7 Millimeter
  • Outer Diameter: 10 Millimeter
HOP-AP

  • Skin stapler/staple, non-bioabsorbable
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution

  • 00858012005878 ()
DSC014-03-US

  • Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005861 ()
D4D0192

  • Basic diagnostic x-ray system application software
No Description
Avive Solutions, Inc.
AED01
In Commercial Distribution

  • 00860002508559 ()


  • Rechargeable public automated external defibrillator
No Description
Medicomp
MC-4425
In Commercial Distribution

  • 10858409005600 ()
  • 00858409005603 ()
MC-4425

  • Straight/elbow breathing circuit connector, single-use
DenteShield Sample Opaque with Fluoride
ELEVATE ORAL CARE, LLC
685DSSAMP
Not in Commercial Distribution

  • 00858290006598 ()


  • Dental unfilled resin sealant/coating
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00150
Not in Commercial Distribution

  • 00873263001509 ()
FC1008

  • Neurosurgical micro targeting drive
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00144
Not in Commercial Distribution

  • 00873263001448 ()
FC1008

  • Neurosurgical micro targeting drive
microTargeting Controller with encoder option for use with STar and mT Drives
FHC, INC.
FC1007-00143
In Commercial Distribution

  • 00873263001431 ()
FC1007

  • Neurosurgical micro targeting drive
The MRI Stretcher with Fowler positioning is non-magnetic, all aluminum, and designed for heavy-duty use.
Mirion Technologies (capintec), Inc.
240-110
In Commercial Distribution

  • 00879942070767 ()
240-110

  • MRI system table, non-powered
Hemorrhage Occluder Pin Large - 14 mm head
SURGIN SURGICAL INSTRUMENTATION, INC.
CR1014
In Commercial Distribution

  • 00868742000111 ()
  • 10868742000118 ()

  • Width: 14 Millimeter
CR1014

  • Haemorrhage control pin
Hemorrhage Occluder Pin Standard - 10 mm head
SURGIN SURGICAL INSTRUMENTATION, INC.
CR1007
In Commercial Distribution

  • 00868742000104 ()
  • 10868742000101 ()

  • Width: 10 Millimeter
CR1007

  • Haemorrhage control pin
No Description
Medicomp
MC-6605
In Commercial Distribution

  • 10858409005389 ()
  • 00858409005382 ()
MC-6605

  • Anaesthesia breathing circuit, single-use
The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-001-00025
In Commercial Distribution

  • 00858395006332 ()
  • 00858395006349 ()
GW-MOL-PI10

  • Dental delivery system instrument unit, electric
The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-001-00023
In Commercial Distribution

  • 00858395006325 ()
GW-MOL-PI01

  • Dental delivery system instrument unit, electric
The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
SONENDO, INC.
FG-003-00011
In Commercial Distribution

  • 00858395006318 ()
GW-APM-PI01

  • Dental delivery system instrument unit, electric
The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
SONENDO, INC.
FG-003-00010
In Commercial Distribution

  • 00858395006295 ()
  • 00858395006301 ()
GW-APM-PI10

  • Dental delivery system instrument unit, electric
The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
SONENDO, INC.
FG-003-00009
Not in Commercial Distribution

  • 00858395006288 ()
GW-APM-PI01

  • Dental delivery system instrument unit, electric
The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-001-00020
In Commercial Distribution

  • 00858395006257 ()
  • 00858395006264 ()
GW-MOL-PI10

  • Dental delivery system instrument unit, electric
The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
SONENDO, INC.
FG-003-00008
Not in Commercial Distribution

  • 00858395006240 ()
  • 00858395006233 ()
GW-APM-PI10

  • Dental delivery system instrument unit, electric
The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-001-00022
In Commercial Distribution

  • 00858395006189 ()
GW-MOL-PI01

  • Dental delivery system instrument unit, electric
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