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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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Stable-L Interbody 36x28x18, 24 Deg
NEXUS SPINE, L.L.C.
525188S
In Commercial Distribution

  • B678525188S0 ()


  • Metallic spinal interbody fusion cage
Stable-L Interbody 36x28x18, 24 Deg
NEXUS SPINE, L.L.C.
525188
In Commercial Distribution

  • B6785251880 ()


  • Metallic spinal interbody fusion cage
Flex Disc 24 ct. Box
The Flex Company
10260
In Commercial Distribution

  • 00851906007040 ()
  • 00850037498413 ()
  • 20850037498417 ()
  • 30850037498414 ()


  • Menstrual cup/disc, non-latex, single-use
The LungQ software produces reproducible CT values for pulmonary tissue, providing quantitative support for diagnosis, selection of patients for treatment, treatment planning, and follow-up examinations. LungQ can be used to support the physician in the diagnosis, evaluation and documentation of pulmonary tissue images (e.g. abnormalities) from CT thoracic datasets. Analysis provided includes segmentation and isolation of sub-compartments, volumetric analysis, tissue destruction, density evaluations, airway and vessel evaluation, fissure evaluation and reporting tools.
Thirona B.V.
v3.y.z
In Commercial Distribution

  • 08719326703817 ()


  • Radiology DICOM image processing application software
Dose Calibrator Read Out Unit
Comecer Netherlands B.V.
0203010016
In Commercial Distribution

  • 08719324589024 ()


  • Radioisotope calibration system
Measuring unit for the dose calibrator
Comecer Netherlands B.V.
0202020001
In Commercial Distribution

  • 08719324589000 ()


  • Radioisotope calibration system
The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
QUANTEL MEDICAL
AXIALIS
In Commercial Distribution

  • 03700542625941 ()


  • Ophthalmic ultrasound imaging system
The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Zeiss mode) is a photocoagulator device intended for the treatment of retinal diseases.
QUANTEL MEDICAL
EASYRET
In Commercial Distribution

  • 03700542625927 ()


  • Ophthalmic solid-state laser system
The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the retinal diseases and glaucoma.
QUANTEL MEDICAL
VITRA 810
In Commercial Distribution

  • 03700542625613 ()


  • Ophthalmic solid-state laser system
The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye.
QUANTEL MEDICAL
VITRA 2
In Commercial Distribution

  • 03700542625569 ()


  • Ophthalmic solid-state laser system
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