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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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Juvéderm ULTRA 2x0.55mL
Allergan, Inc.
96206
In Commercial Distribution

  • 10888628044739 ()
  • 10888628044746 ()

  • 30G 2x0.55mL
96206

  • Dermal tissue reconstructive material, microbe-derived
STYLE 410, LX, 625G BIOCELL |textured|contour|silicone
Allergan, Inc.
LX-410625
Not in Commercial Distribution

  • 10888628003392 ()

  • 625 cc
LX-410625

  • Silicone gel-filled breast implant, textured-surface
STYLE 410, LX, 570G BIOCELL |textured|contour|silicone
Allergan, Inc.
LX-410570
Not in Commercial Distribution

  • 10888628003385 ()

  • 570 cc
LX-410570

  • Silicone gel-filled breast implant, textured-surface
STYLE 410, LX, 515G BIOCELL |textured|contour|silicone
Allergan, Inc.
LX-410515
Not in Commercial Distribution

  • 10888628003378 ()

  • 515 cc
LX-410515

  • Silicone gel-filled breast implant, textured-surface
STYLE 410, FM, 180G
Allergan, Inc.
FM-410180
Not in Commercial Distribution

  • 10888628002807 ()

  • 180 cc
FM-410180

  • Silicone gel-filled breast implant
STYLE 410, FM, 155G
Allergan, Inc.
FM-410155
Not in Commercial Distribution

  • 10888628002791 ()

  • 155 cc
FM-410155

  • Silicone gel-filled breast implant
STYLE 410, FF, 160G
Allergan, Inc.
FF-410160
Not in Commercial Distribution

  • 10888628002616 ()

  • 160 cc
FF-410160

  • Silicone gel-filled breast implant
i-FACTOR™ Putty, 5.0 cc Syringe
Cerapedics Inc.
700-050
In Commercial Distribution

700-050

  • Bone matrix implant, animal-derived, bioabsorbable
i-FACTOR Putty, 1.0cc Syringe
Cerapedics Inc.
700-010
In Commercial Distribution

700-010

  • Bone matrix implant, animal-derived, bioabsorbable
The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture.
Oxford Immunotec, Inc.
TSK.910
In Commercial Distribution

  • 05051716000186 ()
TSK.910US

  • T lymphocyte magnetic separation reagent IVD
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