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.
14181-10
In Commercial Distribution

  • 08718755000962 ()


  • 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.
14315-10-01
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
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 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
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 170 mm
In Commercial Distribution

  • 10855068008713 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 170 Millimeter
CRS-075-170-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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 160 mm
In Commercial Distribution

  • 10855068008706 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 160 Millimeter
CRS-075-160-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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 150 mm
In Commercial Distribution

  • 10855068008690 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 150 Millimeter
CRS-075-150-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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 140 mm
In Commercial Distribution

  • 10855068008683 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 140 Millimeter
CRS-075-140-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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 130 mm
In Commercial Distribution

  • 10855068008676 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 130 Millimeter
CRS-075-130-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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 120 mm
In Commercial Distribution

  • 10855068008669 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 120 Millimeter
CRS-075-120-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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 110 mm
In Commercial Distribution

  • 10855068008652 ()

  • Length: 110 Millimeter
  • Outer Diameter: 7.5 Millimeter
CRS-075-110-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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 100 mm
In Commercial Distribution

  • 10855068008645 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 100 Millimeter
CRS-075-100-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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 90 mm
In Commercial Distribution

  • 10855068008638 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 90 Millimeter
CRS-075-090-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 210 MM, Self Tapping
In Commercial Distribution

  • 10855068008102 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 210 Millimeter
CRS-095-210-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 200 MM, Self Tapping
In Commercial Distribution

  • 10855068008096 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 200 Millimeter
CRS-095-200-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 190 MM, Self Tapping
In Commercial Distribution

  • 10855068008089 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 190 Millimeter
CRS-095-190-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 180 MM, Self Tapping
In Commercial Distribution

  • 10855068008072 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 180 Millimeter
CRS-095-180-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 170 MM, Self Tapping
In Commercial Distribution

  • 10855068008065 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 170 Millimeter
CRS-095-170-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 160 MM, Self Tapping
In Commercial Distribution

  • 10855068008058 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 160 Millimeter
CRS-095-160-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 150 MM, Self Tapping
In Commercial Distribution

  • 10855068008041 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 150 Millimeter
CRS-095-150-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 140 MM, Self Tapping
In Commercial Distribution

  • 10855068008034 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 140 Millimeter
CRS-095-140-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 130 MM, Self Tapping
In Commercial Distribution

  • 10855068008027 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 130 Millimeter
CRS-095-130-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 120 MM, Self Tapping
In Commercial Distribution

  • 10855068008010 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 120 Millimeter
CRS-095-120-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
9.5 MM x 110 MM, Self Tapping
In Commercial Distribution

  • 10855068008003 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 110 Millimeter
CRS-095-110-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid state large-sized detector, specifically designed to be integrated in radiology diagnostic rooms and emergency rooms. Opera D4000RF allows radiological diagnostic examinations to be performed in real time on the skeleton, the gastro-intestinal tract, the vascular system and urogenital system.
GENERAL MEDICAL MERATE SPA
OPERA D4000RF
In Commercial Distribution

  • 08054890480123 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid state large-sized detector, specifically designed to be integrated in radiology diagnostic rooms and emergency rooms. Opera D4000RF allows radiological diagnostic examinations to be performed in real time on the skeleton, the gastro-intestinal tract, the vascular system and urogenital system.
GENERAL MEDICAL MERATE SPA
OPERA D4000RF
In Commercial Distribution

  • 08054890480079 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid state large-sized detector, specifically designed to be integrated in radiology diagnostic rooms and emergency rooms. Opera D4000RF allows radiological diagnostic examinations to be performed in real time on the skeleton, the gastro-intestinal tract, the vascular system and urogenital system.
GENERAL MEDICAL MERATE SPA
OPERA D4000RF
In Commercial Distribution

  • 08054890480048 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
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
Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.
Meta Biomed Co., Ltd.
9476
In Commercial Distribution

  • 08806387894766 ()


  • Endodontic temporary cement
Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.
Meta Biomed Co., Ltd.
9485
In Commercial Distribution

  • 08806387894858 ()


  • Endodontic temporary cement
10.47 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
WCM WASTE & COMPLIANCE MANAGEMENT INC
SMS10000
In Commercial Distribution

  • 10858629005039 ()
  • 00858629005032 ()
SMS10000

  • Sharps container
5.97 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
WCM WASTE & COMPLIANCE MANAGEMENT INC
SMS4000
In Commercial Distribution

  • 10858629005022 ()
  • 00858629005025 ()
SMS4000

  • Sharps container
3.3 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
WCM WASTE & COMPLIANCE MANAGEMENT INC
SMS2400
In Commercial Distribution

  • 10858629005015 ()
  • 00858629005018 ()
SMS2400

  • Sharps container
0.98 liter sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
WCM WASTE & COMPLIANCE MANAGEMENT INC
SRS800
In Commercial Distribution

  • 20858629005005 ()
  • 10858629005008 ()
  • 00858629005001 ()
SRS800

  • Sharps container
This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide.The state of the treatment can be confirmed by the radiopacity of iodoform contained.Metapex Plus is used for patients of all ages requiring root canal treatment.
Meta Biomed Co., Ltd.
9482
In Commercial Distribution

  • 08806387894827 ()


  • Endodontic temporary cement
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