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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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Structurally encoded implant 15mm long, 3.5mm diameter, sterile packed. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-15-35
In Commercial Distribution

  • 00810005666732 ()

  • Length: 15 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Structurally encoded implant 14mm long, 3.5mm diameter, sterile packed. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-14-35
In Commercial Distribution

  • 00810005666725 ()

  • Length: 14 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Structurally encoded implant 13mm long, 3.5mm diameter, sterile packed. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-13-35
In Commercial Distribution

  • 00810005666718 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 13 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
882EV series suction regulator is a continuous subglottic suction regulator .It can be used for medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning etc.
GENTEC(SHANGHAI)CORPORATION
882EV-70 
Not in Commercial Distribution

  • 06970966662618 ()


  • Tracheal suction vacuum regulator
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
LD TECHNOLOGY, LLC
D001
In Commercial Distribution

  • B322D0011 ()


  • Pulse oximeter, line-powered
The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefractometer, keratometer, corneal topographer, tonometer, multi-slit pachymeter, tear-film analyzer , and retro illumination. The VX130+ is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris
LUNEAU TECHNOLOGY OPERATIONS
DNEye Scanner 2
In Commercial Distribution

  • 03664188000923 ()


  • Automated ophthalmic refractometer
  • Ophthalmic tonometer, battery-operated
Examination Gloves
KIMBERLY-CLARK GLOBAL SALES, LLC
55093
In Commercial Distribution

  • 20036000550935 ()
  • 10036000550938 ()
  • 90036000550934 ()
55093-54

  • Nitrile examination/treatment glove, non-powdered, sterile
Examination Gloves
KIMBERLY-CLARK GLOBAL SALES, LLC
55092
In Commercial Distribution

  • 20036000550928 ()
  • 10036000550921 ()
  • 90036000550927 ()
55092-54

  • Nitrile examination/treatment glove, non-powdered, sterile
Examination Gloves
KIMBERLY-CLARK GLOBAL SALES, LLC
53132
In Commercial Distribution

  • 20036000531323 ()
  • 10036000531326 ()
  • 90036000531322 ()
53132-54

  • Nitrile examination/treatment glove, non-powdered, sterile
Examination Gloves
KIMBERLY-CLARK GLOBAL SALES, LLC
53131
In Commercial Distribution

  • 20036000531316 ()
  • 10036000531319 ()
  • 90036000531315 ()
53131-54

  • Nitrile examination/treatment glove, non-powdered, sterile
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