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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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TransLaminar Screw, Partial Thread, Ø5.5 x 40mm
NEXXT SPINE, LLC
14-09-5540
In Commercial Distribution

  • 00889929019733 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
TransLaminar Screw, Partial Thread, Ø4.5 x 40mm
NEXXT SPINE, LLC
14-09-4540
In Commercial Distribution

  • 00889929019719 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
TransLaminar Screw, Partial Thread, Ø4.5 x 20mm
NEXXT SPINE, LLC
14-09-4520
In Commercial Distribution

  • 00889929019689 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 20 Millimeter


  • Spinal bone screw, non-bioabsorbable
SICAT OPTIMOTION
SiCAT GmbH & Co. KG
10501
In Commercial Distribution

  • D776105010 ()
10501

  • Custom-made mouthguard
A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient device.
JTECH Medical
CT012
In Commercial Distribution

  • G041CT0120 ()


  • Joint/spinal manipulator, mechanical
A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient.
JTECH Medical
CT006
In Commercial Distribution

  • G041CT0060 ()


  • Joint/spinal manipulator, mechanical
A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient.
JTECH Medical
CT001
In Commercial Distribution

  • G041CT0010 ()


  • Joint/spinal manipulator, mechanical
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
Size: 3.2 cm; Type: Clear
Boston Medical Products, Inc.
60-101
In Commercial Distribution

  • EBES601010 ()
  • EBES601011 ()

  • Outer Diameter: 32 Millimeter
60-101

  • Nasal septal button
High Pressure Nephrostomy Balloon Catheter Kit
BOSTON SCIENTIFIC CORPORATION
M0062101600
In Commercial Distribution

  • 08714729834540 ()

  • 8 mm Diameter
  • 24 F Diameter
  • 12 cm Effective Length


  • Nephrostomy catheter
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