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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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Madsen - 05713315009013

Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100
Natus Medical Denmark ApS
1012 OTOflex Cavity set
In Commercial Distribution

  • 05713315009013 ()
8-67-41300

  • Impedance audiometer

nanOss® 3D Plus™ - 00846468087128

resorbable porous calcium phosphate bone void filler 25 x 100 x 8mm; 20 cc
Pioneer Surgical Technology, Inc.
90-400-251008
Not in Commercial Distribution

  • 00846468087128 ()
90-400-251008

  • Bone matrix implant, composite

nanOss® 3D Plus™ - 00846468087111

resorbable porous calcium phosphate bone void filler 25 x 50 x 8mm; 10 cc
Pioneer Surgical Technology, Inc.
90-400-25508
Not in Commercial Distribution

  • 00846468087111 ()
90-400-25508

  • Bone matrix implant, composite

nanOss® 3D Plus™ - 00846468087104

resorbable porous calcium phosphate bone void filler 25 x 50 x 4mm; 5 cc
Pioneer Surgical Technology, Inc.
90-400-25504
Not in Commercial Distribution

  • 00846468087104 ()
90-400-25504

  • Bone matrix implant, composite

Dover - 10192253026832

SILICONE ELASTOMER COATED LATEX T.U.R.P. FOLEY CATHETER, 30-50 CC, 3-WAY, 24 FR (8.0 MM)
Cardinal Health 200, LLC
8887649245
In Commercial Distribution

  • 20192253026839 ()
  • 10192253026832 ()
  • 50192253026830 ()
8887649245

  • Single-administration urethral drainage/irrigation catheter

Dover - 10192253026825

SILICONE ELASTOMER COATED LATEX T.U.R.P. FOLEY CATHETER, 30-50 CC, 3-WAY, 22 FR (7.3 MM)
Cardinal Health 200, LLC
8887649229
In Commercial Distribution

  • 20192253026822 ()
  • 10192253026825 ()
  • 50192253026823 ()
8887649229

  • Single-administration urethral drainage/irrigation catheter

Dover - 10192253027778

HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY
Cardinal Health 200, LLC
3044
In Commercial Distribution

  • 50192253027776 ()
  • 10192253027778 ()

  • Total Volume: 5 Milliliter
  • Catheter Gauge: 18 French
3044-

  • Indwelling urethral catheterization kit, adult

Dover - 10192253027617

SILICONE ELASTOMER COATED LATEX T.U.R.P FOLEY CATHETER, 30-50 CC, 2-WAY, 22 FR (7.3 MM)
Cardinal Health 200, LLC
8887648221
In Commercial Distribution

  • 20192253027614 ()
  • 10192253027617 ()
  • 50192253027615 ()

  • Catheter Gauge: 22 French
8887648221-

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253026856

PEDIATRIC SILICONE ELASTOMER COATED LATEX FOLEY CATHETER, 3 CC, 2-WAY, 10 FR (3.3 MM)
Cardinal Health 200, LLC
8887654104
In Commercial Distribution

  • 20192253026853 ()
  • 10192253026856 ()
  • 50192253026854 ()
8887654104

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253026849

PEDIATRIC SILICONE ELASTOMER COATED LATEX FOLEY CATHETER, 3 CC, 2-WAY, 8 FR (2.7 MM)
Cardinal Health 200, LLC
8887654088
In Commercial Distribution

  • 20192253026846 ()
  • 10192253026849 ()
  • 50192253026847 ()
8887654088

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
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