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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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SINGLE SITE CHOLE KIT 3 - 20607915125800

Kit Contains: CY050, 5x38cm EPIX INLINE DISSCT 10/BX CB050, 5x38cm EPIX INLINE SCISSORS 10/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM
APPLIED MEDICAL RESOURCES CORPORATION
CK103
In Commercial Distribution

  • 20607915125800 ()


  • Laparoscopic multi-instrument access port, single-use
  • Tissue extraction bag
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic electrosurgical blunt dissector
  • Ligation clip, metallic

SINGLE SITE CHOLE KIT 3 - 20607915120874

Kit Contains: CY050, 5x38cm EPIX INLINE DISSCT 10/BX CB050, 5x38cm EPIX INLINE SCISSORS 10/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM
APPLIED MEDICAL RESOURCES CORPORATION
CK103
In Commercial Distribution

  • 20607915120874 ()


  • Laparoscopic multi-instrument access port, single-use
  • Tissue extraction bag
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic electrosurgical blunt dissector
  • Ligation clip, metallic

Plus - 07290016633245

Firm
INMODE M.D LTD
AG605904A
In Commercial Distribution

  • 07290016633245 ()
AS601654A

  • Radio-frequency skin surface treatment system

MiniFX - 07290016633238

MiniFX
INMODE M.D LTD
AG604696A
In Commercial Distribution

  • 07290016633238 ()
AG604696A

  • Radio-frequency skin surface treatment system

BodyFX - 07290016633085

BodyFX
INMODE M.D LTD
AS600874A
In Commercial Distribution

  • 07290016633085 ()
AS600874A

  • Radio-frequency skin surface treatment system

VISIONIX - 03664188000039

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 Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT) Meibomian glands imaging Evaluation of tear meniscus height
LUNEAU TECHNOLOGY OPERATIONS
VX130+
In Commercial Distribution

  • 03664188000039 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated

VISIONIX - 03664188001203

The VX120 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, tonometer, pachymeter and retro illumination.
LUNEAU TECHNOLOGY OPERATIONS
VX120
In Commercial Distribution

  • 03664188001203 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated

VISIONIX - 03664188000909

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
VX130
In Commercial Distribution

  • 03664188000909 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated

VISIONIX - 03664188000046

The VX120+ is a multi-function diagnostic device combining 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 cornea. Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT) Meibomian glands imaging Evaluation of tear meniscus height
LUNEAU TECHNOLOGY OPERATIONS
VX120+
In Commercial Distribution

  • 03664188000046 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated

iCare ST500 - 06430033851883

iCare ST500 tonometer
ICARE FINLAND OY
TA04
In Commercial Distribution

  • 06430033851883 ()


  • Ophthalmic tonometer, battery-operated
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