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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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COMPANION 80 1.1 CC ELECTRODE, BOX OF 6
DJO, LLC
5000044
In Commercial Distribution

  • 00888912151405 ()


  • Drug-delivery iontophoresis system electrode, active
.5 CC 31 Gauge X 8 MM 3600
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
.5 CC 31 Gauge X 8 MM 3600
In Commercial Distribution

  • 10817169021954 ()


  • Insulin syringe/needle, basic
AFIBER, FLOWABLE ALLOGRAFT FIBER BONE MATRIX, 10.0 CC
HYHTE HOLDINGS, INC.
JBCB00100
In Commercial Distribution

  • 00840085272356 ()
JBCB00100

  • Vertebral bone filler, bioabsorbable
AFIBER, FLOWABLE ALLOGRAFT FIBER BONE MATRIX, 5.0 CC
HYHTE HOLDINGS, INC.
JBCB00050
In Commercial Distribution

  • 00840085272349 ()
JBCB00050

  • Vertebral bone filler, bioabsorbable
AFIBER, BONE MORPHOGENETIC PROTEIN FIBER ALLOGRAFT, 15.0 CC
HYHTE HOLDINGS, INC.
JBAC00150
In Commercial Distribution

  • 00840085272332 ()
JBAC00150

  • Vertebral bone filler, bioabsorbable
AFIBER, BONE MORPHOGENETIC PROTEIN FIBER ALLOGRAFT, 10.0 CC
HYHTE HOLDINGS, INC.
JBAC00100
In Commercial Distribution

  • 00840085272325 ()
JBAC00100

  • Vertebral bone filler, bioabsorbable
AFIBER, BONE MORPHOGENETIC PROTEIN FIBER ALLOGRAFT, 5.0 CC
HYHTE HOLDINGS, INC.
JBAC00050
In Commercial Distribution

  • 00840085272318 ()
JBAC00050

  • Vertebral bone filler, bioabsorbable
AFIBER, BONE MORPHOGENETIC PROTEIN FIBER ALLOGRAFT, 2.5 CC
HYHTE HOLDINGS, INC.
JBAC00025
In Commercial Distribution

  • 00840085272301 ()
JBAC00025

  • Vertebral bone filler, bioabsorbable
750 cc; Accepts Standard 22mm ID Corrugated Tubing
Dynarex Corporation
34201
In Commercial Distribution

  • 00840117312005 ()
  • 00840117311992 ()


  • Thermal vapour lung treatment system drainage bag
MIS 3.9MM BC ACHILLES SPDBRG W/ FT CC
ARTHREX, INC.
AR-9928BH-MIS
In Commercial Distribution

  • 00888867389557 ()
AR-9928BH-MIS

  • Tendon/ligament bone anchor, bioabsorbable
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