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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3.75mm dia.14mm long variable screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-375-14V
In Commercial Distribution

  • 90810005669125 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 14 Millimeter


  • Intervertebral-body internal spinal fixation system
4.25mm dia.14mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-425-14F
In Commercial Distribution

  • 90810005669064 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 14 Millimeter


  • Intervertebral-body internal spinal fixation system
4.25mm dia.12mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-425-12F
In Commercial Distribution

  • 90810005669057 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • Intervertebral-body internal spinal fixation system
Prime Calibrator Cartridge CCS Comp 300 Sample
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524278 ()
52427

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
  • Assisted reproduction centrifuge tube
No Description
NORTHGATE TECHNOLOGIES INC.
7-700-00
In Commercial Distribution

  • 00817183020684 ()


  • Surgical plume evacuation system
The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
MiE medical imaging electronics GmbH
ECAM-SCINTRON
In Commercial Distribution

  • 04260484140036 ()


  • Stationary gamma camera system
KWV-LT : KwikVac Liquid Trap / 20pcs in one box
Medisourcenet, Inc
KWV-LT
In Commercial Distribution

  • 00850034735030 ()


  • Surgical plume evacuation system
KWV-DT : KwikVac Detecto, Automatic Activation Device / 1 each
Medisourcenet, Inc
KWV-DT
In Commercial Distribution

  • 00850034735016 ()


  • Surgical plume evacuation system
KWV-F : KwikVac Smoke Evacuation Filter / 1 each
Medisourcenet, Inc
KWV-F
In Commercial Distribution

  • 00850034735023 ()
  • 10850034735020 ()


  • Surgical plume evacuation system
KWV-M : KwikVac Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit (1pc)
Medisourcenet, Inc
KWV-M
In Commercial Distribution

  • 00850034735009 ()


  • Surgical plume evacuation system
The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
MET 1 TECHNOLOGIES, LLC
04-07G
In Commercial Distribution

  • 00819824028691 ()
04-07G

  • Bone graft packing block
Connector, Smoke Evacuator to Tubing, 22mm I.D., non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2155
Not in Commercial Distribution

  • 10614559102060 ()


  • Surgical plume evacuation system
E-Z LINK
MEGADYNE MEDICAL PRODUCTS, INC.
MGEZLINK01
In Commercial Distribution

  • 10614559104460 ()
MGEZLINK01

  • Surgical plume evacuation system
Connector Smoke Evacuator Universal Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2150J
In Commercial Distribution

  • 10614559105405 ()
  • 30614559105409 ()
2150J

  • Surgical plume evacuation system
Connector 22mm ID Filter to Tubing Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2145J
In Commercial Distribution

  • 10614559105399 ()
  • 30614559105393 ()
2145J

  • Surgical plume evacuation system
Mega Vac Connector Filter to Tubing Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2140J
In Commercial Distribution

  • 10614559105382 ()
  • 30614559105386 ()
2140J

  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing, 22mm Connector
MEGADYNE MEDICAL PRODUCTS, INC.
252510EC
In Commercial Distribution

  • 10614559105344 ()
  • 30614559105348 ()
252510EC

  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
252510ECBN
Not in Commercial Distribution

  • 30614559105119 ()
  • 10614559105115 ()


  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
252510BN
Not in Commercial Distribution

  • 30614559105102 ()
  • 10614559105108 ()


  • Surgical plume evacuation system
Megadyne Smoke Evacuator Connect Cable, 2.1m
MEGADYNE MEDICAL PRODUCTS, INC.
2406J
In Commercial Distribution

  • 10614559104668 ()
  • 30614559104662 ()
2406J

  • Surgical plume evacuation system
Megadyne Smoke Evacuator Connect Cable, 1m
MEGADYNE MEDICAL PRODUCTS, INC.
2403J
In Commercial Distribution

  • 10614559104651 ()
  • 30614559104655 ()
2403J

  • Surgical plume evacuation system
Megadyne Smoke Evacuator
MEGADYNE MEDICAL PRODUCTS, INC.
MESE1
In Commercial Distribution

  • 10614559104545 ()
MESE1

  • Surgical plume evacuation system
Mini Vac Surgical Smoke Evacuator 120v
MEGADYNE MEDICAL PRODUCTS, INC.
ECVV120
Not in Commercial Distribution

  • 10614559104422 ()
  • 30614559104426 ()


  • Surgical plume evacuation system
EQM-A : EvaQMax Auto Automatic Activation Device / 1 each/ reusable
MEDIMAX TECH INC.
EQM-A
In Commercial Distribution

  • 00817325023610 ()


  • Surgical plume evacuation system
EQM-FT : EvaQMax Fluid Trap - Fluid Trap for Unit / 20 pcs in one box / Each
MEDIMAX TECH INC.
EQM-FT
In Commercial Distribution

  • 00817325023603 ()


  • Surgical plume evacuation system
EQM-CAF : EvaQMax Filter for the EvaQMax Unit / each/ reusable
MEDIMAX TECH INC.
EQM-CAF
In Commercial Distribution

  • 10817325023570 ()
  • 00817325023573 ()


  • Surgical plume evacuation system
4 Level, 94mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-94
In Commercial Distribution

  • 111106494 ()
  • M364111106FD4940 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 90mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-90
In Commercial Distribution

  • 111106490 ()
  • M364111106FD4900 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 86mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-86
In Commercial Distribution

  • 111106486 ()
  • M364111106FD4860 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 82mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-82
In Commercial Distribution

  • 111106482 ()
  • M364111106FD4820 ()


  • Spinal fixation plate, non-bioabsorbable
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