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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

Spect Ophthalmic Camera - 00853501008002

The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Spect Inc.
BOM001
In Commercial Distribution

  • 00853501008002 ()


  • Ophthalmic fundus camera

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

ER920 Braemar - B146ER9B0

ENHANCED ALGORITHM ECG EVENT RECORDER https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652#
BRAEMAR MANUFACTURING, LLC
900-0557-01
In Commercial Distribution

  • B146ER9B0 ()


  • Electrocardiography telemetric monitoring system

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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