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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-BCE41-1
In Commercial Distribution

  • 05712821000316 ()
HBE-BCE41-1

  • Dental implant suprastructure, permanent, preformed
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
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
Genie Medical BAHS 2022.1 DVD. ISO file for this software is 5712149026999
Oticon Medical AB
235649
In Commercial Distribution

  • 05712149026982 ()
235649

  • Audiometric/hearing device software
Genie Medical BAHS 2022.1 USB. ISO file for this software is 5712149026999
Oticon Medical AB
235639
In Commercial Distribution

  • 05712149026975 ()
235639

  • Audiometric/hearing device software
SENTIO TI IMPLANT KIT
Oticon Medical AB
186323
In Commercial Distribution

  • 05712149026906 ()
186323

  • Implantable vibrator bone-conduction hearing implant system
Genie Medical BAHS 2021.2 DVD. ISO file for this software is 5712149026876
Oticon Medical AB
226483
In Commercial Distribution

  • 05712149026814 ()
226483

  • Audiometric/hearing device software
Genie Medical BAHS 2021.2 USB. ISO file for this software is 5712149026876
Oticon Medical AB
226479
In Commercial Distribution

  • 05712149026807 ()
226479

  • Audiometric/hearing device software
Softband 5, Bilateral XS/S Red
Oticon Medical AB
227709
In Commercial Distribution

  • 05712149026791 ()
227709

  • Head-worn bone-conduction hearing aid holder, reusable
Softband 5, Bilateral XS/S Navy Blue
Oticon Medical AB
227708
In Commercial Distribution

  • 05712149026784 ()
227708

  • Head-worn bone-conduction hearing aid holder, reusable
Softband 5, Bilateral XS/S Pink
Oticon Medical AB
227707
In Commercial Distribution

  • 05712149026777 ()
227707

  • Head-worn bone-conduction hearing aid holder, reusable
Softband 5, Bilateral XS/S Light Blue
Oticon Medical AB
227706
In Commercial Distribution

  • 05712149026760 ()
227706

  • Head-worn bone-conduction hearing aid holder, reusable
Softband 5, Bilateral XS/S Beige
Oticon Medical AB
227705
In Commercial Distribution

  • 05712149026753 ()
227705

  • Head-worn bone-conduction hearing aid holder, reusable
TOTAL HIP ONE AND TWO PACK
MEDLINE INDUSTRIES, INC.
DYNJ67508B
In Commercial Distribution

  • 10195327206628 ()
DYNJ67508B

  • General surgical procedure kit, non-medicated, single-use
LONE STAR II
MEDLINE INDUSTRIES, INC.
VAL006EYLSB
In Commercial Distribution

  • 40195327206599 ()
  • 10195327206598 ()
VAL006EYLSB

  • General surgical procedure kit, non-medicated, single-use
DR BOONE
MEDLINE INDUSTRIES, INC.
DYNJ903857F
In Commercial Distribution

  • 10889942961351 ()
DYNJ903857F

  • General surgical procedure kit, non-medicated, single-use
ORTHO HAND DR MELONE PACK
MEDLINE INDUSTRIES, INC.
DYNJ55232A
In Commercial Distribution

  • 10889942960644 ()
DYNJ55232A

  • General surgical procedure kit, non-medicated, single-use
No Description
WestGroupe Optical Inc
K-571 STONE BLACK
In Commercial Distribution

  • 00676190279269 ()


  • Spectacle frame
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