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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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ROMEO 2 INSTRUMENTATION - 07640151081997

REDUCER QR
SpineArt SA
ELL-IN 10 34-N
In Commercial Distribution

  • 07640151081997 ()
ELL-IN 10 34-N

  • Orthopaedic rod reducer

ROMEO 2 INSTRUMENTATION - 07640151081904

SETSCREW HOLDER W
SpineArt SA
ELL-IN 03 10-N
In Commercial Distribution

  • 07640151081904 ()
ELL-IN 03 10-N

  • Surgical implant/trial-implant/sizer holder, reusable

Case 2 Complete - 00817766026461

Case 2 Complete
Tecomet
2500-00-794
In Commercial Distribution

  • 00817766026461 ()


  • Device sterilization/disinfection container, reusable

H-Endodontic Drill # 2 - 08059388442782

No Description
OVERFIBERS SRL
H-Endodontic Drill # 2
In Commercial Distribution

  • 08059388442782 ()
HED202

  • Rotary/reciprocating endodontic file/rasp, reusable

Over Post+ # 2 - 08059388441235

No Description
OVERFIBERS SRL
Over Post+ # 2
In Commercial Distribution

  • 08059388443239 ()
  • 08059388441235 ()
PP702

  • Root canal post, preformed

Prosthetic Drill # 2 - 08059388440450

No Description
OVERFIBERS SRL
Prosthetic Drill # 2
In Commercial Distribution

  • 08059388440450 ()
PD102

  • Rotary/reciprocating endodontic file/rasp, reusable

Polygon Drill # 2 - 08059388440382

No Description
OVERFIBERS SRL
Polygon Drill # 2
In Commercial Distribution

  • 08059388440382 ()
PYD02

  • Rotary/reciprocating endodontic file/rasp, reusable

Endontic Drill # 2 - 08059388440245

No Description
OVERFIBERS SRL
Endontic Drill # 2
In Commercial Distribution

  • 08059388440245 ()
ED202

  • Rotary/reciprocating endodontic file/rasp, reusable

Elite 2 System - 00821925003484

Elite 2 System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr (8.5 mm)
Gyrus ACMI, LLC
E2RIS-CF25
In Commercial Distribution

  • 00821925003484 ()


  • Endoscope sheath, reusable

Elite 2 System - 00821925003477

Elite 2 System Continuous Flow Resectoscope Outer Sheath 27.5 Fr (9.2 mm)
Gyrus ACMI, LLC
E2OS-CF27
In Commercial Distribution

  • 00821925003477 ()


  • Endoscope sheath, reusable
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