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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 zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
ZYGOFIX LTD
1
In Commercial Distribution

  • 07290019421153 ()
ZFT-100

  • Spinal bone screw, non-bioabsorbable
PrimaLOK FF 45mm Implant Assembly
OSTEOMED LLC
800-1145
Not in Commercial Distribution

  • 00845694031219 ()

  • Length: 45 Millimeter
800-1145

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-sterile
PrimaLOK FF 40mm Implant Assembly
OSTEOMED LLC
800-1140
Not in Commercial Distribution

  • 00845694031202 ()

  • Length: 40 Millimeter
800-1140

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-sterile
PrimaLOK FF 35mm Implant Assembly
OSTEOMED LLC
800-1135
Not in Commercial Distribution

  • 00845694031196 ()

  • Length: 35 Millimeter
800-1135

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-sterile
PrimaLOK FF 30mm Implant Assembly
OSTEOMED LLC
800-1130
Not in Commercial Distribution

  • 00845694031189 ()

  • Length: 30 Millimeter
800-1130

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-sterile
PrimaLOK FF 25mm Implant Assembly
OSTEOMED LLC
800-1125
Not in Commercial Distribution

  • 00845694031172 ()

  • Length: 25 Millimeter
800-1125

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-sterile
Processes DNA sample data files of Class I and Class II Human Leukocyte Antigens (HLA) for analysis and HLA allele assignment by comparison to the IMGT/HLA database with uTYPE. The sample data files are generated from samples processed with SeCore™ SBT Sequencing kits or GSSP SBT Sequencing kits and the Applied Biosystems Genetic Analyzer.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021765 ()
539993

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888623
Not in Commercial Distribution

  • 10888234400394 ()
888623

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)
The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreation centers, health and fitness clubs, universities, and professional sports teams. The Korebalance® System uses the latest in interactive technology, offering innovative high-tech balance assessment and training. Backed by over two decades of medical experience, the Korebalance® will provide you and your patients with the best possible documented neurosensory assessment and training.
Diversified Healthcare Development, LLC
KB01
In Commercial Distribution

  • 00858458007009 ()


  • Balance/cognitive function analysis system
The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
Compremium AG
1
In Commercial Distribution

  • G247CPMX10 ()
  • G247CPMX12 ()


  • Compartmental-pressure monitoring system, reusable
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