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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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ONLINE DAT Amphetamines II - 07613336120996

No Description
Roche Diagnostics GmbH
08056781190
In Commercial Distribution

  • 07613336120996 ()
08056781190

  • Amphetamine/methamphetamine group IVD, reagent

discovery® - J011728702850

Assort. discovery® pearl,McLaugh.18,15-45 / Brackets / For further information please visit our online-
DENTAURUM GmbH & Co.KG
718-702-85
In Commercial Distribution

  • J011728702850 ()


  • Orthodontic bracket, ceramic

HOLOSCOPE - 07290018862018

No Description
REAL VIEW IMAGING LTD
HOLOSCOPE-i
In Commercial Distribution

  • 07290018862018 ()


  • Ultrasound imaging system workstation
  • CT system workstation

NA - 00643169777316

PLNG STATION 9734048R STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048R
In Commercial Distribution

  • 00643169777316 ()


  • Stereotactic surgery system workstation

TQE Plus Endotoxin 20" Filter Flat 222 Head - 00868277000457

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-20HP3E
In Commercial Distribution

  • 10868277000454 ()
  • 00868277000457 ()
  • 20868277000451 ()


  • Haemodialysis system dialysate pyrogen filter

TQE Plus Endotoxin 10" Filter Flat 222 Head - 00868277000440

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-10HP3E
In Commercial Distribution

  • 10868277000447 ()
  • 00868277000440 ()
  • 20868277000444 ()


  • Haemodialysis system dialysate pyrogen filter

Synergy - 00613994532398

PLNG STATION 9734048 STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048
In Commercial Distribution

  • 00613994532398 ()


  • Stereotactic surgery system workstation

Stealthstation® S7™ - 00613994792921

PLNG STATION 9734669R RWK S7
MEDTRONIC NAVIGATION, INC.
9734669R
In Commercial Distribution

  • 00613994792921 ()


  • Stereotactic surgery system workstation

Nipro Ultrafilter - 00383790008860

Filter for clean dialysate and water
NIPRO MEDICAL CORPORATION
CF+609N
In Commercial Distribution

  • 40383790008868 ()
  • 00383790008860 ()


  • Haemodialysis system dialysate pyrogen filter

StealthStation® AXIEM™ System - 00613994109477

AXIEM KIT, 9732750, PORTABLE PRE-BUILD
MEDTRONIC NAVIGATION, INC.
9732750
In Commercial Distribution

  • 00613994109477 ()


  • Stereotactic surgery system workstation
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