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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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Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter - 00801741046261

Bardex® Lubri-Sil® 400 Series Temperature Sensing All-Silicone 3 cc Foley Catheter
C. R. Bard, Inc.
119208M
In Commercial Distribution

  • 10801741046268 ()
  • 00801741046261 ()

  • Catheter Gauge: 8 French
119208M

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM - 18053340341035

RIVAL TI CC PLATE LARGE (present record replaces device with Primary DI: 18053800893517
ORTHOFIX SRL
2
In Commercial Distribution

  • 18053340341035 ()
002-G-01030

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM - 18053340341028

RIVAL TI CC PLATE MEDIUM (present record replaces device with Primary DI: 18053800893500
ORTHOFIX SRL
2
In Commercial Distribution

  • 18053340341028 ()
002-G-01025

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM - 18053340341011

RIVAL TI CC PLATE SMALL (present record replaces device with Primary DI: 18053800893494
ORTHOFIX SRL
2
In Commercial Distribution

  • 18053340341011 ()
002-G-01020

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

ComPel Surgical Gown - 00634916003796

OR GWN ULT COMPEL NEGA BL XL - CC TT BL/WHT SFTY STCH CONST
STANDARD TEXTILE CO., INC.
75656694
In Commercial Distribution

  • 00634916003796 ()
  • 10634916003796 ()
75656694

  • Surgical gown, reusable

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

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 - 10192253058420

SILICONE ELASTOMER COATED LATEX T.U.R.P. FOLEY CATHETER, 30-50 CC, 2-WAY, 24 FR (8.0 MM)
Cardinal Health 200, LLC
8887648247
In Commercial Distribution

  • 20192253058427 ()
  • 10192253058420 ()
  • 50192253058428 ()
8887648247

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
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