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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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TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons. IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days).
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
In Commercial Distribution

  • 00860003478707 ()
000-0219

  • Multi-parameter urinary monitoring system catheter set
No Description
BLUEGRASS VASCULAR TECHNOLOGIES, INC.
600200/A
In Commercial Distribution

  • 00860003451601 ()
  • 10860003451608 ()
600200/A

  • Central venous catheter inside-out introduction set
No Description
CPRP LLC
CPRP Pillow
In Commercial Distribution

  • 00860003440100 ()


  • Freestanding patient positioner, reusable
ClearFit VDI Large
LONGEVITI NEURO SOLUTIONS LLC
171718
In Commercial Distribution

  • 00860003416310 ()


  • Cranial resinous compound
ClearFit VDI Standard
LONGEVITI NEURO SOLUTIONS LLC
171716
In Commercial Distribution

  • 00860003416303 ()


  • Cranial resinous compound
Calibration Plate, Disposable
Lumicell, Inc.
810-00214
In Commercial Distribution

  • 00860008537829 ()
  • 10860003252564 ()
  • 00860003252567 ()


  • Intraoperative tumour margin fluorescence imaging system probe calibrator
Sterile Cover
Lumicell, Inc.
810-00210
In Commercial Distribution

  • 00860003252512 ()
  • 00860003252505 ()
  • 00860008537812 ()


  • Intraoperative tumour margin fluorescence imaging system probe cover/spacer
Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics and software.
Canary Medical USA LLC
43-5570-030-14
In Commercial Distribution

  • 00860003118399 ()


  • Knee femur stem prosthesis
The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized during by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona Personalized Knee System.
Canary Medical USA LLC
43-5570-058-14
In Commercial Distribution

  • 00860003118306 ()


  • Knee femur stem prosthesis
Flexible Access Port Kit
Cannuflow, Inc.
SportPort 6.5 x 6
In Commercial Distribution

  • 20860002896940 ()
  • 00860002896946 ()

  • Lumen/Inner Diameter: 6.5 Millimeter
  • Length: 6 Centimeter
Sport 6-6

  • Arthroscopic access cannula, single-use
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