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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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The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14315-10-01
In Commercial Distribution

  • 08718755000955 ()


  • Multichannel radiation survey meter
The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14315-10
In Commercial Distribution

  • 08718755000948 ()


  • Multichannel radiation survey meter
The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series
Varex Imaging Nederland B.V.
13034-10
In Commercial Distribution

  • 08718755000931 ()


  • Multichannel radiation survey meter
The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
12860-10
In Commercial Distribution

  • 08718755000924 ()


  • Multichannel radiation survey meter
FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.
NanoEnTek, Inc.
FRBR 015
In Commercial Distribution

  • 08809317540825 ()
FRBR 015

  • Immunohistochemistry endogenous protein blocking reagent IVD
Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
BIOPSY DIGIT AM
In Commercial Distribution

  • 18033837190216 ()
  • 08033837190219 ()

  • Height: 347 Millimeter
  • Depth: 303 Millimeter
  • Width: 350 Millimeter
9100-01

  • Mammographic stereotactic biopsy system
The Nidek Mirante Scanning Laser Ophthalmoscope is an ophthalmic imaging device that allows non invasive and non-contact observation of the shape and the disease state of the fundus, anterior segment, and retina using a scanning laser ophthalmoscope (hereafter referred to as “SLO”) and/or optical coherence tomography (hereafter referred to as “OCT”).
NIDEK CO.,LTD.
Mirante
In Commercial Distribution

  • 04987669101568 ()


  • Scanning-laser retinal imaging system
  • Retinal optical coherence tomography system
The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.
EL.EN. SPA
M112B1
In Commercial Distribution

  • 08057017760221 ()
M112B1

  • Dermatological solid-state laser system
The DEKA Motus AY is a medical device quipped with a 755nm and 1064nm solid state laser sources. The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.
EL.EN. SPA
M115B1
In Commercial Distribution

  • 08057017760344 ()
M115B1

  • Multi-modality skin surface treatment system
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
7.5 mm x 180 mm
In Commercial Distribution

  • 10855068008720 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 180 Millimeter
CRS-075-180-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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