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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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Stainless Steel spring handle Singles Acupuncture Needles are sterile disposable, The needle length is 40mm length .
Wuxi Jiajian Medical Instrument Co.,Ltd.
0.20*40
In Commercial Distribution

  • 16972011710104 ()
  • 06972011710107 ()


  • Acupuncture needle, single-use
Stainless Steel spring handle Singles Acupuncture Needles are sterile disposable, The needle length is 25mm length .
Wuxi Jiajian Medical Instrument Co.,Ltd.
0.25*25
In Commercial Distribution

  • 16972011710043 ()
  • 06972011710046 ()


  • Acupuncture needle, single-use
The Silicone Tubing Set™ is intended for flushing of donor lungs in preparation for transplantation.
Xvivo Perfusion AB
19005
In Commercial Distribution

  • 07350069520043 ()
19005

  • Surgical irrigation tubing set, single-use
Solum IV 5cc w/ BMC Plus Processing Kit - UDI is not correct per current DI# configuration.
Celling Biosciences
1205-2000
Not in Commercial Distribution

  • 00810025870089 ()
XXXX

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Synthetic bone graft
XTRUDER is intended for extrusion of acrylic resins or bone void fillers prepared with Tecres SHAKIT.
TECRES SPA
ASA0390
In Commercial Distribution

  • 28031497001436 ()


  • Orthopaedic cement preparation/delivery kit
The Polyflux 17L is intended for hemodialysis, for the treatment of chronic or acute renal failure
Gambro Dialysatoren GmbH
17L
In Commercial Distribution

  • 37332414036417 ()
  • 07332414036416 ()

  • Area/Surface Area: 1.7 Square meter
102058

  • Hollow-fibre haemodialysis dialyser, single-use
The AngioAssist Docking Station is intended to stabilize and load guidewires and catheters during percutaneous procedures.
Vascular Solutions, Inc.
8151
Not in Commercial Distribution

  • M20681511 ()
  • M20681510 ()


  • Medical device rail
The EndoCervex-Brush®-S is a single-use cell sampler Intended to collect endocervical cells in women.
Rovers Medical Devices B.V.
380100745
In Commercial Distribution

  • 28719189246296 ()
  • 18719189246299 ()
  • 08719189246520 ()
  • 08719189246292 ()


  • Cytology scraper, single-use
It is used to connect the water inlet and outlet of the hysteroscope for circulating perfusion.
Suzhou AcuVu medical technology Co., Ltd.
5mm×7mm×600mm
In Commercial Distribution

  • 26974880990691 ()
  • 06974880990697 ()


  • Fluid transfer tube, general-purpose
It is used to connect the water inlet and outlet of the hysteroscope for circulating perfusion.
Suzhou AcuVu medical technology Co., Ltd.
5mm×7mm×600mm
In Commercial Distribution

  • 26974880990684 ()
  • 06974880990680 ()


  • Fluid transfer tube, general-purpose
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