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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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PTSX407 PTS-X BALLOON 40MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613724
In Commercial Distribution

  • 04046955677382 ()
613724

  • Cardiac sizing catheter
PTSX360 PTS-X BALLOON 35MM X 6CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613723
In Commercial Distribution

  • 04046955677368 ()
613723

  • Cardiac sizing catheter
PTSX358 PTS-X BALLOON 35MM X 4CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613722
In Commercial Distribution

  • 04046955677344 ()
613722

  • Cardiac sizing catheter
PTSX308 PTS-X BALLOON 30MM X 5CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613721
In Commercial Distribution

  • 04046955677320 ()
613721

  • Cardiac sizing catheter
PTSX307 PTS-X BALLOON 30MM X 4CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613720
In Commercial Distribution

  • 04046955677306 ()
613720

  • Cardiac sizing catheter
PTSX306 PTS-X BALLOON 30MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613719
In Commercial Distribution

  • 04046955677283 ()
613719

  • Cardiac sizing catheter
PTSX255 PTS-X BALLOON 25MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613718
In Commercial Distribution

  • 04046955677269 ()
613718

  • Cardiac sizing catheter
PTSX206 PTS-X BALLOON 20MM X 4CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613717
In Commercial Distribution

  • 04046955677245 ()
613717

  • Cardiac sizing catheter
PTSX205 PTS-X BALLOON 20MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613716
In Commercial Distribution

  • 04046955677221 ()
613716

  • Cardiac sizing catheter
The ZEUS AtheNA Multi-Lyte® ToRCH IgG Plus Test System is intended for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV), HSV-1 and HSV-2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CMV. For HSV-1 and HSV-2, the test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The test is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A81101G
In Commercial Distribution

  • 00845533000093 ()
A81101G

  • Multiple infectious organism/newborn TORCH screen IVD, kit, fluorescent immunoassay
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