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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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Smooth Moderate High Profile, 150cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB150
In Commercial Distribution

  • 10081317031175 ()
SMHB-150

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 545cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB545
In Commercial Distribution

  • 10081317031151 ()
SMHB-545

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 500cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB500
In Commercial Distribution

  • 10081317031144 ()
SMHB-500

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 470cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB470
In Commercial Distribution

  • 10081317031137 ()
SMHB-470

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 580cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB580
In Commercial Distribution

  • 10081317031120 ()
SMHB-580

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 435cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB435
In Commercial Distribution

  • 10081317031113 ()
SMHB-435

  • Silicone gel-filled breast implant, smooth-surface
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, 2.5cc Syringe
Cerapedics Inc.
700-025
In Commercial Distribution

700-025

  • 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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