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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 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 18mm Prep Kit
In Commercial Distribution

  • 00815432027569 ()
7300-1800

  • Orthopaedic implant aiming/guiding block, reusable
  • Orthopaedic implant aiming/guiding block, single-use
  • Orthopaedic broach
  • Surgical drill guide, reusable
  • Surgical drill guide, single-use
The Integra Total Foot System Dwyer Displacement Plate has an in step design to stabilize medial-displacement osteotomies at the calcaneus. This plate is used for the rearfoot.
Ascension Orthopedics, Inc.
2806210
In Commercial Distribution

  • M26928062101 ()
  • 10381780119609 ()

  • 10 mm step
2806210

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Dwyer Displacement Plate has an in step design to stabilize medial-displacement osteotomies at the calcaneus. This plate is used for the rearfoot.
Ascension Orthopedics, Inc.
2806208
In Commercial Distribution

  • M26928062081 ()
  • 10381780119593 ()

  • 8 mm step
2806208

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Dwyer Displacement Plate has an in step design to stabilize medial-displacement osteotomies at the calcaneus. This plate is used for the rearfoot.
Ascension Orthopedics, Inc.
2806206
In Commercial Distribution

  • M26928062061 ()
  • 10381780119586 ()

  • 6 mm step
2806206

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Sensifirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
EL GLOBAL TRADE LTD
CEL100US04SNS
In Commercial Distribution

  • 05060445341309 ()


  • Radio-frequency skin surface treatment system
The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
EL GLOBAL TRADE LTD
CEL100US01SNS
In Commercial Distribution

  • 05060445341118 ()


  • Radio-frequency skin surface treatment system
SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.
OPUS KSD, INC.
404010
In Commercial Distribution

  • 00867469000206 ()
  • 10867469000203 ()


  • Skin stapler
The Trabectome I/A Console (110V) is an aspiration pump intended for use in general surgery applications where aspiration of irrigation waste and waste fluid is desired.
NEOMEDIX CORPORATION
550014
In Commercial Distribution

  • 00854028002023 ()
550014-01

  • Ophthalmic irrigation/aspiration pump
The VX220 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: keratometer, corneal topographer, tonometer,and pachymeter and retro illumination
LUNEAU TECHNOLOGY OPERATIONS
VX220
In Commercial Distribution

  • 03664188002200 ()


  • Ophthalmic tonometer, battery-operated
  • Optical pachymeter
The VX118 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, pachymeter and retro illumination.
LUNEAU TECHNOLOGY OPERATIONS
VX118
In Commercial Distribution

  • 03664188001180 ()


  • Optical pachymeter
  • Automated ophthalmic refractometer
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