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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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Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 20” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0120
Not in Commercial Distribution

  • 20866318000378 ()
  • 00866318000374 ()
  • 10866318000371 ()


  • Microbial water purification filter, non-sterilizable
No Description
BIOANALYTIC GmbH, biomed. Analysentechnik
004013-6010
In Commercial Distribution

  • 04061609000187 ()
  • 04061609000590 ()


  • White blood cell count IVD, reagent
No Description
BIOANALYTIC GmbH, biomed. Analysentechnik
004013-0006
In Commercial Distribution

  • 04061609000149 ()
  • 04061609000590 ()


  • White blood cell count IVD, reagent
No Description
BIOANALYTIC GmbH, biomed. Analysentechnik
003605-6100
In Commercial Distribution

  • 04061609000040 ()
  • 04061609000552 ()


  • Sperm concentration indicator IVD, reagent
For microscopic counting of Sperms. (100 Tests)
BIOANALYTIC GmbH, biomed. Analysentechnik
003604-6100
In Commercial Distribution

  • 04061609000026 ()
  • 04061609000545 ()


  • Sperm concentration indicator IVD, reagent
No Description
Drägerwerk AG & Co. KGaA
MP05770
In Commercial Distribution

  • 04048675665748 ()


  • Microbial medical gas filter, single-use
No Description
Drägerwerk AG & Co. KGaA
MP03702
In Commercial Distribution

  • 04048675303725 ()
  • 04048675445241 ()


  • Nasal oxygen cannula, CPAP
No Description
Drägerwerk AG & Co. KGaA
MP03701
In Commercial Distribution

  • 04048675303718 ()
  • 04048675445234 ()


  • Nasal oxygen cannula, CPAP
No Description
Drägerwerk AG & Co. KGaA
MP03700
In Commercial Distribution

  • 04048675303701 ()
  • 04048675445227 ()


  • Nasal oxygen cannula, CPAP
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844115213 ()

  • 13x9x24mm
TRT20130924

  • Metallic spinal interbody fusion cage
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