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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aScope Colon US version
Ambu A/S
484001000US
In Commercial Distribution

  • 05707480154807 ()
  • 05707480154791 ()
484001000US

  • Flexible video colonoscope, single-use
Skin Temperature Probe 400TM
Covidien LP
90045
In Commercial Distribution

  • 20884521817545 ()
  • 10884521817548 ()
  • 30884521817542 ()


  • General-purpose patient temperature probe, single-use
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
9mm Acorn TPS M
STRYKER CORPORATION
5220030290
In Commercial Distribution

  • 07613327582024 ()

  • Diameter: 9.0 Millimeter
5220-030-290

  • Cranial bur, single-use
OrthAlign Plus Unit - Gap Balancing (US)
Orthalign, Inc.
403001-08-US
In Commercial Distribution

  • 00810832031987 ()
403001-08-US

  • Orthopaedic surgical procedure kit, non-medicated, reusable
OrthAlign Plus Unit - P3 (US)
Orthalign, Inc.
403001-07-US
In Commercial Distribution

  • 00810832031970 ()
403001-07-US

  • Orthopaedic stereotactic surgery system
OrthAlign Plus Unit - Gap Balancing (JP)
Orthalign, Inc.
403001-08-JP
In Commercial Distribution

  • 00810832031956 ()
403001-08-JP

  • Orthopaedic surgical procedure kit, non-medicated, reusable
OrthAlign Plus Unit - P3 (JP)
Orthalign, Inc.
403001-07-JP
In Commercial Distribution

  • 00810832031949 ()
403001-07-JP

  • Orthopaedic stereotactic surgery system
OrthAlign Plus Unit - Gap Balancing (EU)
Orthalign, Inc.
403001-08-CE
In Commercial Distribution

  • 00810832031833 ()
403001-08-CE

  • Orthopaedic surgical procedure kit, non-medicated, reusable
OrthAlign Plus Unit - P3 (EU)
Orthalign, Inc.
403001-07-CE
In Commercial Distribution

  • 00810832031796 ()
403001-07-CE

  • Orthopaedic stereotactic surgery system
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