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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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LifeSPARC Blood Pump Kit with 29 Fr ProtekDuo Veno-Venous Cannula
CARDIACASSIST, INC.
5820-2916
Not in Commercial Distribution

  • 00814112020784 ()


  • Vascular dilator, single-use
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
CLIP EX0411421 SUTURE
MEDTRONIC SOFAMOR DANEK, INC.
EX0411421
In Commercial Distribution

  • 00613994994851 ()


  • Surgical flat-nosed pliers
HOLDER EX07101273 ROD REDUCED PROFILE
MEDTRONIC SOFAMOR DANEK, INC.
EX07101273
In Commercial Distribution

  • 00613994871343 ()


  • Surgical flat-nosed pliers
Hystro Sheath Double Seal Luer Cap is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
HYST01
In Commercial Distribution

  • 00848657076241 ()
HYST01

  • Endoscope working-channel valve, reusable
ROD EX0112015 GRIPPER 5.5/6.0 VICE
MEDTRONIC SOFAMOR DANEK, INC.
EX0112015
In Commercial Distribution

  • 00643169121669 ()


  • Surgical flat-nosed pliers
INTRODUCER EX1111572 4.75 ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1111572
In Commercial Distribution

  • 00643169106024 ()


  • Surgical flat-nosed pliers
GRIPPER EX0811554 ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0811554
In Commercial Distribution

  • 00643169078284 ()


  • Surgical flat-nosed pliers
GRIPPER X0712187 4.75 ROD
MEDTRONIC SOFAMOR DANEK, INC.
X0712187
In Commercial Distribution

  • 00643169233928 ()


  • Surgical flat-nosed pliers
GRIPPER EX0512098 5.5MM ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0512098
In Commercial Distribution

  • 00643169181601 ()


  • Surgical flat-nosed pliers
PLIERS EX0412079 DISTRACTOR 5.5/6.0
MEDTRONIC SOFAMOR DANEK, INC.
EX0412079
In Commercial Distribution

  • 00643169177628 ()


  • Surgical flat-nosed pliers
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