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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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Advanced Bionics, LLC
CI-4207
In Commercial Distribution



  • Cochlear implant system
DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate- buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.
BIOVENTUS LLC
1082020
In Commercial Distribution

  • 00816986020808 ()
  • 10816986020805 ()
  • 89130-2020-1 ()
1082020

  • Synovial fluid supplementation medium
IPG, SESR01, SENSIA, SR, IS-1, US
MEDTRONIC, INC.
SESR01
In Commercial Distribution

  • 00613994223807 ()


  • Single-chamber implantable pacemaker, rate-responsive
IPG, ADSR06, ADAPTA SR 5/6 UNI, CTD, US
MEDTRONIC, INC.
ADSR06
Not in Commercial Distribution

  • 00613994222190 ()


  • Single-chamber implantable pacemaker, rate-responsive
IPG, ADSR03, ADAPTA, SR, 3.2 MM, US
MEDTRONIC, INC.
ADSR03
Not in Commercial Distribution

  • 00613994222176 ()


  • Single-chamber implantable pacemaker, rate-responsive
IPG ADSR01P ADAPTA SR IS-1 CTD US
MEDTRONIC, INC.
ADSR01P
Not in Commercial Distribution

  • 00613994222169 ()


  • Single-chamber implantable pacemaker, rate-responsive
IPG, ADSR01, ADAPTA, SR, IS-1, US
MEDTRONIC, INC.
ADSR01
Not in Commercial Distribution

  • 00613994222152 ()


  • Single-chamber implantable pacemaker, rate-responsive
IPG, SEDR01, SENSIA, DR, IS-1, US
MEDTRONIC, INC.
SEDR01
In Commercial Distribution

  • 00613994222138 ()


  • Dual-chamber implantable pacemaker, rate-responsive
IPG, VEDR01, VERSA, DR, IS-1, US
MEDTRONIC, INC.
VEDR01
Not in Commercial Distribution

  • 00613994222114 ()


  • Dual-chamber implantable pacemaker, rate-responsive
IPG, ADVDD01, ADAPTA, VDD, IS-1, US
MEDTRONIC, INC.
ADVDD01
Not in Commercial Distribution

  • 00613994222107 ()


  • Dual-chamber implantable pacemaker, rate-responsive
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