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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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Canturio® Smart Extension 14mm (D) x 30mm (H) - 00860003118399

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

canturio™te - 00860003118306

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

PuraGel 5mL - 00860001820898

PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (5 ml)
3-D MATRIX INC.
651-006
In Commercial Distribution

  • 00860001820898 ()
651-006

  • Synthetic peptide haemostatic agent

PuraSinus 1mL - 00860001820843

PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (1 mL)
3-D MATRIX INC.
651-007
In Commercial Distribution

  • 00860001820843 ()
651-007

  • Intranasal splint, biodegradable

PuraSinus 3mL - 00860001820836

PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)
3-D MATRIX INC.
651-008
In Commercial Distribution

  • 00860001820836 ()


  • Intranasal splint, biodegradable

PuraSinus 5mL - 00860001820829

PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)
3-D MATRIX INC.
651-009
In Commercial Distribution

  • 00860001820829 ()


  • Intranasal splint, biodegradable

PL-5 - 00860000064590

No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-5
In Commercial Distribution

  • 00860000064590 ()
  • M748PL50 ()


  • Manual brachytherapy source, permanent implant

PL-1 - 00860000064583

No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-1
In Commercial Distribution

  • 00860000064583 ()
  • M748PL10 ()


  • Manual brachytherapy source, permanent implant

CS-1 - 00860000064576

No Description
GT MEDICAL TECHNOLOGIES, INC.
CS-1NS
In Commercial Distribution



  • Manual brachytherapy source, permanent implant

CS-1 - 00860000064569

No Description
GT MEDICAL TECHNOLOGIES, INC.
CS-1
In Commercial Distribution

  • 00860000064569 ()
  • M748CS10 ()


  • Manual brachytherapy source, permanent implant
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