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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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Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in asymmetric sizes.
ADDITION TECHNOLOGY, INC.
ICIA-210/450-150
In Commercial Distribution

  • 00850048576186 ()
11400-210/450-150

  • Intracorneal ring segment
  • Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in asymmetric sizes.
ADDITION TECHNOLOGY, INC.
ICIA-210/400-150
In Commercial Distribution

  • 00850048576179 ()
11400-210/400-150

  • Intracorneal ring segment
  • Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in asymmetric sizes.
ADDITION TECHNOLOGY, INC.
ICIA-210/350-150
In Commercial Distribution

  • 00850048576162 ()
11400-210/350-150

  • Intracorneal ring segment
  • Intracorneal ring
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228034094 ()
874721

  • Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
No Description
Biomet Orthopedics, LLC
103533
In Commercial Distribution

  • 00880304008700 ()

  • 6.5 mm x 30 mm
103533

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Biomet Orthopedics, LLC
103532
In Commercial Distribution

  • 00880304008694 ()

  • 6.5 mm x 25 mm
103532

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Biomet Orthopedics, LLC
103534
In Commercial Distribution

  • 00880304005785 ()

  • 6.5 mm x 35 mm
103534

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Biomet Orthopedics, LLC
103535
In Commercial Distribution

  • 00880304002296 ()

  • 6.5 mm x 40 mm
103535

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Biomet Orthopedics, LLC
103531
In Commercial Distribution

  • 00880304001961 ()

  • 6.5 mm x 20 mm
103531

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Biomet Orthopedics, LLC
103538
In Commercial Distribution

  • 00880304004061 ()

  • 6.5 mm x 60 mm
103538

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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