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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
Base Station (Charger)
Cleartrac Technologies, LLC
BASE-001
In Commercial Distribution
- 00860003114742 ()
- Noninvasive device battery charger
MALE Urine Flow Disposable
Cleartrac Technologies, LLC
UFD-001M
In Commercial Distribution
- 00860003114735 ()
- Urine flowmeter, single-use
FEMALE Urine Flow Disposable
Cleartrac Technologies, LLC
UFD-001F
In Commercial Distribution
- 00860003114728 ()
- Urine flowmeter, single-use
AbsorbaleGelatin Sponge
Orca Products, LLC
Standard
Not in Commercial Distribution
- 10860003109912 ()
- 00860003109915 ()
- 00860003109922 ()
- Gelatin haemostatic agent
UPER ARM BLOOD PRESSURE MONITOR
TRUE INTEGRAL INC
JPD-HA120
In Commercial Distribution
- 00860003079744 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
UPER ARM BLOOD PRESSURE MONITOR
TRUE INTEGRAL INC
DBP-1359
In Commercial Distribution
- 00860003079737 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
No- contact infarared body thermometer
TRUE INTEGRAL INC
HTD8813C
In Commercial Distribution
- 00860003079720 ()
- Infrared patient thermometer, skin
INFRARED FOREHEAD THERMOMETER
TRUE INTEGRAL INC
DET-306
In Commercial Distribution
- 00860003079713 ()
- Infrared patient thermometer, skin
Intelligent Mesh Nebulizer
TRUE INTEGRAL INC
NEB002
In Commercial Distribution
- 00860003079706 ()
- Benchtop nebulizer, non-heated