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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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ECS is a hand held and operated crown splitter. A vertical cut is made into the crown by a cutting wheel and the crown splitter is inserted into the cut. The splitter is squeezed and the unit tip separates and splits the crown open.
Taub Products
1 mm
In Commercial Distribution

  • D8379911500 ()
99-1150

  • Dental prosthesis removal instrument
The 700 Single Lens Billboard Case base is fabricated from a low-density polypropylene plastic resin. The overall length is approximately 2.240 in., width is approximately 1.050 in. and height approximately 0.450 in. It has a single lens well and is paired with the Plain cap.
Paragon Vision Sciences, Inc.
700
In Commercial Distribution

  • B222700 ()
  • B2227009 ()


  • Contact lens case
The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SM-200-003
In Commercial Distribution

  • B815SM2000030 ()
SM-200-003

  • Haemodialysis blood tubing set, single-use
The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-400-00
In Commercial Distribution

  • B815SA400000 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use
The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-300-00
In Commercial Distribution

  • B815SA300000 ()
SA-300-00

  • Haemodialysis blood tubing set, single-use
The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
DI-400-00
In Commercial Distribution

  • B815DI400000 ()
DI-400-00

  • Haemodialysis blood tubing set, single-use
The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Spectral Medical Inc
SM-200-003
Not in Commercial Distribution

  • B173SM2000030 ()
SM-200-003

  • Haemodialysis blood tubing set, single-use
The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Spectral Medical Inc
SA-400-00
Not in Commercial Distribution

  • B173SA400000 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use
The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
I-Dialco Inc
SA-400-00
In Commercial Distribution

  • 07540161930226 ()
  • 17540161930223 ()
  • 27540161930220 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use
The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data management functions. The Echo Lumena is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping.
IMMUCOR, INC.
0086998
In Commercial Distribution

  • 10888234002338 ()
0086998

  • Immunohaematology/blood bank analyser IVD
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