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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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Insulin Pen Needles 32G 6mm 50cnt
HOME AIDE DIAGNOSTICS, INC.
INSP32-6
In Commercial Distribution

  • 10860003125530 ()
  • 00860003125533 ()

  • Length: 4 Millimeter
  • Needle Gauge: 32 Gauge


  • Hypodermic needle, single-use
Insulin Pen Needles 32G 5mm 50cnt
HOME AIDE DIAGNOSTICS, INC.
INSP32-5
In Commercial Distribution

  • 10860003125523 ()
  • 00860003125526 ()

  • Length: 4 Millimeter
  • Needle Gauge: 32 Gauge


  • Hypodermic needle, single-use
Insulin Pen Needles 32G 4mm 50cnt
HOME AIDE DIAGNOSTICS, INC.
INSP32-4
In Commercial Distribution

  • 10860003125516 ()
  • 00860003125519 ()

  • Length: 4 Millimeter
  • Needle Gauge: 32 Gauge


  • Hypodermic needle, single-use
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
AbsorbaleGelatin Sponge
Orca Products, LLC
Standard
Not in Commercial Distribution

  • 10860003109912 ()
  • 00860003109915 ()
  • 00860003109922 ()


  • Gelatin haemostatic agent
No Description
CONCURE ONCOLOGY, INC.
80-FN1720
In Commercial Distribution

  • 00860003072769 ()


  • Manual brachytherapy system
No Description
CONCURE ONCOLOGY, INC.
97-FN1720
In Commercial Distribution

  • 00860003072752 ()


  • Manual brachytherapy system
No Description
CLR Medical
S012-01-015
In Commercial Distribution

  • 00850052377014 ()
  • 00860003054994 ()


  • Closed-wound drain connection tubing set
No Description
CLR Medical
CLR Irrigation & Drainage Kit
In Commercial Distribution

  • 00860003054949 ()
  • 00860003054970 ()
S012-01-200

  • Surgical irrigation/aspiration cannula, non-illuminating, single-use
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