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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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OraQuick Advance Rapid HIV 1/2 Antibody Test - 00608337000016

No Description
Orasure Technologies, Inc.
3001-1197
In Commercial Distribution

  • 20608337000010 ()
  • 00608337000016 ()
  • 10608337000013 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Bulkamid - 10810005340509

Bulkamid Urethral Bulking System 2mL
AXONICS MODULATION TECHNOLOGIES, INC.
50050
In Commercial Distribution

  • 10810005340509 ()


  • Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable

Bulkamid - 10810005340493

Bulkamid 3mL
AXONICS MODULATION TECHNOLOGIES, INC.
60030
In Commercial Distribution

  • 10810005340493 ()


  • Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable

Durasphere ® EXP - 00858015005011

Injectable Bulking Agent
Carbon Medical Technologies, Inc.
890-216
In Commercial Distribution

  • 00858015005011 ()

  • Total Volume: 3 Milliliter
890-216

  • Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable

Durasphere ® EXP - 00858015005004

Injectable Bulking Agent
Carbon Medical Technologies, Inc.
890-215
In Commercial Distribution

  • 00858015005004 ()

  • Total Volume: 1 Milliliter
890-215

  • Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable

Deflux® - 00365649922039

Deflux® is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.
SALIX PHARMACEUTICALS, LTD.
1092203
In Commercial Distribution

  • 00365649922039 ()
  • 10365649922036 ()


  • Urinary tract reconstructive material, microbe-derived

Deflux - 00850004725009

Deflux injectable gel
PALETTE LIFE SCIENCES, INC.
Gel 1.0 mL Syringe
In Commercial Distribution

  • 00850004725009 ()

  • Total Volume: 1 Milliliter
011504

  • Urinary tract reconstructive material, microbe-derived

Locator™ - 05414734501248

Deflectable stylet
ST. JUDE MEDICAL, INC.
1292-58
In Commercial Distribution

  • 05414734501248 ()

  • Length: 58 Centimeter
1292-58

  • Pacing/defibrillation lead stylet

Locator™ - 05414734501231

Deflectable stylet
ST. JUDE MEDICAL, INC.
1292-52
In Commercial Distribution

  • 05414734501231 ()

  • Length: 52 Centimeter
1292-52

  • Pacing/defibrillation lead stylet

Locator™ - 05414734501224

Deflectable stylet
ST. JUDE MEDICAL, INC.
1292-46
In Commercial Distribution

  • 05414734501224 ()

  • Length: 46 Centimeter
1292-46

  • Pacing/defibrillation lead stylet
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