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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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D-Handle Small, AO, Black
MIAMI DEVICE SOLUTIONS LLC
MDS000609AO
In Commercial Distribution

  • 10812269025802 ()
MDS000609AO

  • Surgical instrument handle, non-torque-limiting
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Torque Limiter T-Handle, AO, 1.5Nm, Green
MIAMI DEVICE SOLUTIONS LLC
MDS000605AOT
In Commercial Distribution

  • 10812269022689 ()
MDS000605AOT

  • Surgical instrument handle, non-torque-limiting
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
E-Handle Medium, AO, Black
MIAMI DEVICE SOLUTIONS LLC
MDS000605AO
In Commercial Distribution

  • 10812269022672 ()
MDS000605AO

  • Surgical instrument handle, non-torque-limiting
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
E-Handle, AO, Black
MIAMI DEVICE SOLUTIONS LLC
MDS000606AO
In Commercial Distribution

  • 10812269022658 ()
MDS000606AO

  • Surgical instrument handle, non-torque-limiting
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Ball Handle, AO, Black
MIAMI DEVICE SOLUTIONS LLC
MDS000604AO
In Commercial Distribution

  • 10812269021934 ()
MDS000604AO

  • Surgical instrument handle, non-torque-limiting
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
S0-Handle, AO, Black
MIAMI DEVICE SOLUTIONS LLC
MDS000601AO
In Commercial Distribution

  • 10812269020517 ()
MDS000601AO

  • Surgical instrument handle, non-torque-limiting
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The VX118 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, pachymeter and retro illumination.
LUNEAU TECHNOLOGY OPERATIONS
VX118
In Commercial Distribution

  • 03664188001180 ()


  • Optical pachymeter
  • Automated ophthalmic refractometer
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM CD001, 10mm RETRIEVAL SYSTEM, 10/BX C0R83,12x60 Kii® OPT ZTHR 6/BX C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
CK378
In Commercial Distribution

  • 30607915127795 ()


  • Laparoscopic access cannula, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Tissue extraction bag
  • Laparoscopic multi-instrument access port, single-use
  • Ligation clip, metallic
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution

  • 04987669100530 ()


  • Optical pachymeter
  • Direct ophthalmoscope, line-powered
Lipid and Glucose Measuring System
GERMAINE LABORATORIES, INC
ILM-0001A
In Commercial Distribution

  • 00695684773014 ()


  • Glucose/ketone/lipid profile IVD, kit, enzyme chemiluminescence
  • Glucose IVD, kit, electrometry
  • Glucose IVD, control
  • Total cholesterol lipid IVD, kit, spectrophotometry
  • Total cholesterol lipid IVD, control
  • Triglyceride IVD, control
  • Triglyceride IVD, kit, spectrophotometry
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