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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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Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
1.75x1.75 cm
In Commercial Distribution

  • 05694310960069 ()
  • 05694310960052 ()

  • Width: 1.75 Centimeter
  • Length: 1.75 Centimeter
50200S00B0D

  • Collagen wound matrix dressing
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
7x20 Meshed Burn
In Commercial Distribution

  • 05694310960045 ()
  • 05694310960038 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202M14B0D

  • Collagen wound matrix dressing
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
7x10 Meshed Burn
In Commercial Distribution

  • 05694310960021 ()
  • 05694310960014 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50202M13B0D

  • Collagen wound matrix dressing
The NeckCare Device is used to measure and record head motion during instructed head-neck movements.
NeckCare Holding ehf
NS-110X2
In Commercial Distribution



  • Electronic goniometer/kinesiology sensor
The NeckCare Exercises are used to measure, record, analyze, and report head motion during instructed head-neck movements.
NeckCare Holding ehf
v1.1
In Commercial Distribution

  • 05694230564026 ()


  • Biomechanical function analysis/rehabilitation software
The NeckCare System is used to measure, record, analyze and report head motion during instructed head-neck movements.
NeckCare Holding ehf
NS-110X2
In Commercial Distribution

  • 05694230564019 ()


  • Electronic goniometer/kinesiology sensor
The NeckCare Assessments are used to measure, record, analyze, and report head motion during instructed head-neck movements.
NeckCare Holding ehf
v1.1
In Commercial Distribution



  • Biomechanical function analysis/rehabilitation software
The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Acquisition
In Commercial Distribution



  • Bioelectrical signal analysis software
Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Client Software
In Commercial Distribution



  • Bioelectrical signal analysis software
Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Server Software
In Commercial Distribution



  • Bioelectrical signal analysis software
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