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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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Response™ - 05414734201193

Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401133
In Commercial Distribution

  • 05414734201193 ()

  • Catheter Gauge: 7 French
401133

  • Cardiac mapping catheter, percutaneous, single-use

Response™ - 05414734201179

Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401130
In Commercial Distribution

  • 05414734201179 ()

  • Catheter Gauge: 7 French
401130

  • Cardiac mapping catheter, percutaneous, single-use

Response™ - 05414734201209

Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401134
In Commercial Distribution

  • 05414734201209 ()

  • Catheter Gauge: 7 French
401134

  • Cardiac mapping catheter, percutaneous, single-use

Response™ - 05414734201186

Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401132
In Commercial Distribution

  • 05414734201186 ()

  • Catheter Gauge: 7 French
401132

  • Cardiac mapping catheter, percutaneous, single-use

LuerSafe Adult Angled ThermoShield Bacterial Viral HMEF - 05055788773474

With Self-Sealing Luer Port
FLEXICARE MEDICAL LIMITED
038-41-335LSU
In Commercial Distribution

  • 05055788773474 ()


  • Heat/moisture exchanger/microbial medical gas filter

ALEUTIAN Interbody Systems - 10888857115507

Small T-Handle with Hudson
K2M, INC.
602-90225
In Commercial Distribution

  • 10888857115507 ()
602-90225

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medline Industries, Inc. - 10193489554076

SHOWER KIT WITH CHG
MEDLINE INDUSTRIES, INC.
PACG1071
In Commercial Distribution

  • 10193489554076 ()
  • 40193489554077 ()
PACG1071

  • General surgical procedure kit, non-medicated, single-use

ALEUTIAN® Interbody Systems - 10888857128088

Si T-Handle with Hudson
K2M, INC.
702-90208
In Commercial Distribution

  • 10888857128088 ()
702-90208

  • Surgical instrument handle, non-torque-limiting

TransLoc 3D - 00850026642001

Inserter with Key Bump
Foundation Fusion Solutions, LLC
T05-01
In Commercial Distribution

  • 00850026642001 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

REMI Robotic Navigation System - 00850026574142

Guide Tube with Tracker
Fusion Robotics, LLC
1010
In Commercial Distribution

  • 00850026574142 ()


  • Robotic surgical navigation system
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