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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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XiVE® - EFRI322524352

XiVE® TG plus Implant D3.4/L15
Dentsply Implants Manufacturing GmbH
32252435
Not in Commercial Distribution

  • EFRI322524352 ()
25-2435

  • Screw endosteal dental implant, one-piece

XiVE® - EFRI322524332

XiVE® TG plus Implant D3.4/L13
Dentsply Implants Manufacturing GmbH
32252433
Not in Commercial Distribution

  • EFRI322524332 ()
25-2433

  • Screw endosteal dental implant, one-piece

XiVE® - EFRI322524322

XiVE® TG plus Implant D3.4/L11
Dentsply Implants Manufacturing GmbH
32252432
Not in Commercial Distribution

  • EFRI322524322 ()
25-2432

  • Screw endosteal dental implant, one-piece

XiVE® - EFRI322524312

XiVE® TG plus Implant D3.4/L9.5
Dentsply Implants Manufacturing GmbH
32252431
Not in Commercial Distribution

  • EFRI322524312 ()
25-2431

  • Screw endosteal dental implant, one-piece

N/A - 04250328207841

FUSE PLIF CAGE 8 X 24 MM 0 DEG
MEDTRONIC SOFAMOR DANEK, INC.
FP-08.24.0
In Commercial Distribution

  • 04250328207841 ()

  • 8mm x 24mm x 0 deg


  • Metallic spinal interbody fusion cage

N/A - 04250328207810

FUSE PLIF CAGE 7 X 24 MM 0 DEG
MEDTRONIC SOFAMOR DANEK, INC.
FP-07.24.0
In Commercial Distribution

  • 04250328207810 ()

  • 7mm x 24mm x 0 deg


  • Metallic spinal interbody fusion cage

Stradis Medical, LLC. - M752DC5073C0

Dressing Change Tray W/ Chlorhexidine
STRADIS MEDICAL, LLC
DC-5073C
Not in Commercial Distribution

  • M752DC5073C0 ()
  • M752DC5073C5 ()


  • Wound dressing kit, medicated

iASSIST - 00889024305250

No Description
Orthosoft Inc
20-8011-002-00
In Commercial Distribution

  • 00889024305250 ()
  • 00889024466388 ()
20-8011-002-00

  • Orthopaedic prosthesis implantation positioning instrument, single-use

iASSIST - 00889024305243

No Description
Orthosoft Inc
20-8011-001-00
Not in Commercial Distribution

  • 00889024305243 ()
  • 00889024466371 ()
20-8011-001-00

  • Orthopaedic prosthesis implantation positioning instrument, single-use

ACE - 00614950013449

ACE TWO WAY PLASTIC AUTOMATIC VALVE STERILE DISP L/F 10/PKG
ACE SURGICAL SUPPLY CO., INC.
0031156
In Commercial Distribution

  • 00614950013449 ()
  • 10614950013446 ()
0031156

  • Mechanical expiratory valve, single-use
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