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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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ClearFit VDI Standard
LONGEVITI NEURO SOLUTIONS LLC
171716
In Commercial Distribution

  • 00860003416303 ()


  • Cranial resinous compound
SPIWay Endonasal Access Guide Size Medium
SPIWAY LLC
SP005
In Commercial Distribution

  • 00860003136416 ()
  • 10860003136413 ()
SP005

  • Intranasal splint, non-biodegradable
SPIWay Endonasal Access Guide Size Large
SPIWAY LLC
SP004
In Commercial Distribution

  • 00860003136409 ()
  • 10860003136406 ()
SP004

  • Intranasal splint, non-biodegradable
One handed use No lancing device required Automatic needle retraction Lock out after use prevents needle stick injuries as well as cross-contamination
HOME AIDE DIAGNOSTICS, INC.
PureCSafety100
In Commercial Distribution

  • 10860003125561 ()
  • 00860003125564 ()

  • Needle Gauge: 30 Gauge


  • Manual blood lancing device, 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
Resorbable implant for anterior cruciate ligament (ACL) repair. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
Miach Orthopaedics, Inc.
1000
In Commercial Distribution

  • 00860002987804 ()


  • Joint cartilage biomatrix implant
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
Flexible Access Portal Kit
Cannuflow, Inc.
SportPort 8.5 x 6
In Commercial Distribution

  • 20860002896933 ()
  • 00860002896939 ()

  • Lumen/Inner Diameter: 8.5 Millimeter
  • Length: 6 Centimeter
SPORT 8-6

  • Arthroscopic access cannula, single-use
Flexible endoscope channel dryer
GI Scientific LLC
Endoscope Channel Dryer Large
In Commercial Distribution

  • 00860002853116 ()
  • 00860002853161 ()
VDL-06-00006

  • Surgical instrument/endoscope cleaning utensil, single-use
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