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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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OMEGO - 09120077180083

The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
tyromotion GmbH
1
In Commercial Distribution

  • 09120077180083 ()


  • Treadmill/elliptical gait rehabilitation system

LEXO - 09120077180076

The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.
tyromotion GmbH
R1
In Commercial Distribution

  • 09120077180076 ()


  • Treadmill/elliptical gait rehabilitation system

THERA-Trainer lyra - 04041925002775

The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. The foot plates follow a pattern that is derived from healthy subjects. The body weight support system secures the patient from falling and further allows to reduce the weight on the patient’s feet.
medica - Medizintechnik GmbH
01.XX.XX
In Commercial Distribution

  • 04041925002775 ()


  • Treadmill/elliptical gait rehabilitation system

CardioMD - 05711665002012

Gamma Camera System
X3d ApS
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002012 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system

CorCam - 05711665002005

Gamma Camera System
X3d ApS
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002005 ()

  • Weight: 815 Kilogram
  • Height: 150 Centimeter
  • Depth: 150 Centimeter
  • Width: 284 Centimeter
9COR2370

  • Stationary gamma camera system

W-Bone - 05430001477115

W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA200
In Commercial Distribution

  • 05430001477115 ()

  • Weight: 2.0 Gram


  • Dental bone matrix implant, animal-derived

W-Bone - 05430001477108

W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA100
In Commercial Distribution

  • 05430001477108 ()

  • Weight: 1.0 Gram


  • Dental bone matrix implant, animal-derived

W-Bone - 05430001477092

W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA050
In Commercial Distribution

  • 05430001477092 ()

  • Weight: 0.50 Gram


  • Dental bone matrix implant, animal-derived

W-Bone - 05430001477085

W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA025
In Commercial Distribution

  • 05430001477085 ()

  • Weight: 0.25 Gram


  • Dental bone matrix implant, animal-derived

primaLOK FF - 00813210021990

primaLOK FF 45mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1145-00
In Commercial Distribution

  • 00813210021990 ()

  • Length: 45 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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