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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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The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.
Elos Medtech Pinol A/S
HBE-BCE34-1
In Commercial Distribution

  • 05712821000309 ()
HBE-BCE34-1

  • Dental implant suprastructure, permanent, preformed
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
25730
In Commercial Distribution

  • 05712821000057 ()
  • 05712821009357 ()


  • Surgical torque wrench adaptor
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
25777
In Commercial Distribution

  • 05712821000040 ()
  • 05712821009418 ()


  • Surgical torque wrench adaptor
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
25776
In Commercial Distribution

  • 05712821000033 ()
  • 05712821009395 ()


  • Surgical torque wrench adaptor
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
25775
In Commercial Distribution

  • 05712821000026 ()
  • 05712821009449 ()


  • Surgical torque wrench adaptor
A dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
25774
In Commercial Distribution

  • 05712821000019 ()


  • Dental torque wrench
The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
Vitrolife A/S
16531
In Commercial Distribution

  • 05712714675317 ()
16531

  • Assisted reproduction embryo-assessment software
The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture. The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6). Indications for Use / Intended Use: For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.
Vitrolife A/S
16606
In Commercial Distribution

  • 05712714666063 ()
  • 15712714666060 ()
16606

  • Assisted reproduction procedure dish
The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The nine (9) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture. The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6). Indications for Use / Intended Use: For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.
Vitrolife A/S
16604
In Commercial Distribution

  • 05712714666049 ()
  • 15712714666046 ()
16604

  • Assisted reproduction procedure dish
The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture wells, and each well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient (name, patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10-6 and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.
Vitrolife A/S
16450
In Commercial Distribution

  • 05712714664502 ()
  • 15712714664509 ()
16450

  • Assisted reproduction procedure dish
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