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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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Integra®Ti6® - 10381780245902

Integra® Ti6® The Ti6 TC-Series K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
KW1103
In Commercial Distribution

  • M269KW11031 ()
  • 10381780245902 ()

  • 4.72in L x .043 in Diamter
KW1103

  • Orthopaedic guidewire, reusable

Integra®Ti6® - 10381780245889

Integra® Ti6® The Ti6 TC-Series K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
KW1102
In Commercial Distribution

  • M269KW11021 ()
  • 10381780245889 ()

  • 3.94in L x .035in diameter
KW1102

  • Orthopaedic guidewire, reusable

Cadence™ - 10381780240341

Long Shouldered Bone Pin is used to maintain the placement of other instruments
Ascension Orthopedics, Inc.
10204023
In Commercial Distribution

  • M268102040231 ()
  • 10381780240341 ()

  • 3.12in L x .004in diameter
10204023

  • Joint prosthesis implantation kit, reusable

Cadence™ - 10381780240334

Short Shouldered Bone Pin is used to maintain the placement of other instruments
Ascension Orthopedics, Inc.
10204022
In Commercial Distribution

  • M268102040221 ()
  • 10381780240334 ()
10204022

  • Joint prosthesis implantation kit, reusable

eNcounterCloud - B377GMD306100XXX0

eNcounterCloud is a secure cloud-based web application for medical image archiving and management.
Globalmed Holdings, LLC
2.3.x.x
In Commercial Distribution

  • B377GMD306100XXX0 ()


  • Multidisciplinary medical image management software

TITAN™ - 10381780258155

The Fin-Lock Instrument Tray Base is the botom portion wherein devices are placed.
Ascension Orthopedics, Inc.
CSA-0926-01
In Commercial Distribution

  • M269CSA0926011 ()
  • 10381780258155 ()

  • 21.20 in L x 9.80 in W x 3.79 in H


  • Instrument tray, reusable

Freeman Pancreatic Flexi-Stent Kit - M84965310

Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter. This is a single-use device.
HOBBS MEDICAL, INC.
6531
In Commercial Distribution

  • M84965310 ()
6531

  • Polymeric pancreatic stent, non-bioabsorbable

Freeman Pancreatic Flexi-Stent Kit - M84965300

Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter. This is a single-use device.
HOBBS MEDICAL, INC.
6530
In Commercial Distribution

  • M84965300 ()
6530

  • Polymeric pancreatic stent, non-bioabsorbable

Freeman Pancreatic Flexi-Stent Kit - M84965290

Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter. This is a single-use device.
HOBBS MEDICAL, INC.
6529
In Commercial Distribution

  • M84965290 ()
6529

  • Polymeric pancreatic stent, non-bioabsorbable

Freeman Pancreatic Flexi-Stent Kit - M84965280

Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter. This is a single-use device.
HOBBS MEDICAL, INC.
6528
In Commercial Distribution

  • M84965280 ()
6528

  • Polymeric pancreatic stent, non-bioabsorbable
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