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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 - 00801741046285

Bardex® Lubri-Sil® 400 Series Temperature Sensing All-Silicone 5 cc Foley Catheter
C. R. Bard, Inc.
119212M
In Commercial Distribution

  • 10801741046282 ()
  • 00801741046285 ()

  • Catheter Gauge: 12 French
119212M

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter - 00801741046278

Bardex® Lubri-Sil® 400 Series Temperature Sensing All-Silicone 3 cc Foley Catheter
C. R. Bard, Inc.
119210M
In Commercial Distribution

  • 10801741046275 ()
  • 00801741046278 ()

  • Catheter Gauge: 10 French
119210M

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

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

B-P TOTAL KNEE SYSTEM - 00814193021519

B-P KNEE TIBIA PLATFORM COMPONENT, W/O BIOCOAT, W/ULTRACOAT, TYPE 0, SIZE 2 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
ENDOTEC, INC.
04-32-0462
Not in Commercial Distribution

  • 00814193021519 ()

  • SIZE 2, TYPE 0
04-32-0462

  • Cruciate-retaining total knee prosthesis

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 - 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
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