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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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TriMAX Implant System - 00815432027613

The TriMAX Impant System is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.
CROSSROADS EXTREMITY SYSTEMS
TriMAX 25mm Full Prep Kit
In Commercial Distribution

  • 00815432027613 ()
7300-2500KT

  • Intraoperative bone pin/screw, non-sterile
  • Intraoperative orthopaedic bone pin/screw, single-use
  • Bone-resection orthopaedic reamer, single-use
  • Bone-resection orthopaedic reamer, reprocessed
  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Surgical drill guide, single-use
  • Surgical drill guide, reusable
  • Orthopaedic broach
  • Orthopaedic implant aiming/guiding block, single-use
  • Orthopaedic implant aiming/guiding block, reusable
  • Orthopaedic implant impactor, reusable

TriMAX Implant System - 00815432027606

The TriMAX Impant System is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.
CROSSROADS EXTREMITY SYSTEMS
TriMAX 20mm Full Prep Kit
In Commercial Distribution

  • 00815432027606 ()
7300-2000KT

  • Intraoperative bone pin/screw, non-sterile
  • Intraoperative orthopaedic bone pin/screw, single-use
  • Bone-resection orthopaedic reamer, single-use
  • Bone-resection orthopaedic reamer, reprocessed
  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Surgical drill guide, single-use
  • Surgical drill guide, reusable
  • Orthopaedic broach
  • Orthopaedic implant aiming/guiding block, single-use
  • Orthopaedic implant aiming/guiding block, reusable
  • Orthopaedic implant impactor, reusable

TriMAX Implant System - 00815432027590

The TriMAX Implant System is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.
CROSSROADS EXTREMITY SYSTEMS
TriMAX 18mm Full Prep Kit
In Commercial Distribution

  • 00815432027590 ()

  • 20mm x 20mm x 20mm
7300-1800KT

  • Intraoperative bone pin/screw, non-sterile
  • Intraoperative orthopaedic bone pin/screw, single-use
  • Bone-resection orthopaedic reamer, single-use
  • Bone-resection orthopaedic reamer, reprocessed
  • Orthopaedic implant aiming/guiding block, reusable
  • Orthopaedic implant aiming/guiding block, single-use
  • Orthopaedic broach
  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Surgical drill guide, reusable
  • Surgical drill guide, single-use
  • Orthopaedic implant impactor, reusable

RODENSTOCK - 03664188000923

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

Restoration, orthodontic - 06972677873147

No Description
Modern Dental Laboratory (DG) Co., Ltd.
314
In Commercial Distribution

  • 06972677873154 ()
  • 06972677873147 ()


  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Dental veneer, professional
  • Removable dental occlusal splint, preformed
  • Orthodontic appliance system, bonded
  • Orthodontic retainer

SPECULAR MICROSCOPE - 04987669100530

The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution

  • 04987669100530 ()


  • Optical pachymeter
  • Direct ophthalmoscope, line-powered

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

STRoPP Plantar Plate Repair Kit (Alternate Distractor) - Sterile - 00815432023264

The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
1601-0001
In Commercial Distribution

  • 00815432023264 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0001

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use

STRoPP - 00815432023097

The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
STRoPP Plantar Plate Repair Kit - Sterile
In Commercial Distribution

  • 00815432023097 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0000

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use
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