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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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The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Safeguard US Operating, LLC
15
In Commercial Distribution

  • M68980801D150 ()
80-801-D

  • Blood donor set, single-pack
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. SyMRI can also generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, output from SyMRI can provide information useful in determining diagnosis. SyMRI 2D is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). T1W and T2W images from SyMRI 3D may replace conventional MR images in a clinical setting when interpreting together with a conventional 3D T2W FLAIR image.
SyntheticMR AB (publ)
15
In Commercial Distribution

  • 07340024700078 ()


  • MRI system application software
Test, Pregnancy, Hcg, Over The Counter
Naturalcycles Nordic AB
15
In Commercial Distribution

  • 07350014630155 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
KIT, SMALL, "I". Includes: 127 - HOLDER, CHILD AP-PA HEAD (00810050240307), 132 – SUPPORT, HEAD/NECK, 6.5” x 10” x 12” (00810050240208), 133 – REST, CERVICAL HEAD (00810050240055), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 139 – WEDGE, 7” x 7” x 10” (00810050240345), 169 – RECTANGLE, 3” x 7.5” x 10” (00810050240413)
DOMICO MED-DEVICE, LLC
15
Not in Commercial Distribution

  • 00810050242165 ()


  • Radiological general body-part positioner
  • Radiological headrest
  • Multifunction body cushion
No Description
Directa AB
15
In Commercial Distribution

  • 17310236092152 ()
609215

  • Preformed dental crown, temporary
STAINLESS STEEL NON STERILE SURGICAL BLADE # 15 BARREL POLISHED BULK PACKED MYCO REORDER # 3000-15
NIRAJ INDUSTRIES PRIVATE LIMITED
#15
In Commercial Distribution

  • 58904233125141 ()
  • 18904233125143 ()
  • 08904233125146 ()
02514

  • Manual scalpel blade, single-use
STAINLESS STEEL NON STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #15 BULK PACKED MYCO REORDER # 6000CST-15
NIRAJ INDUSTRIES PRIVATE LIMITED
#15
In Commercial Distribution

  • 28904233117411 ()
  • 18904233117414 ()
  • 58904233117412 ()
  • 08904233117417 ()
01741

  • Scalpel, single-use
15 cm, 15 Fr.
Spiggle & Theis Medizintechnik GmbH
30-748-15
In Commercial Distribution

  • 04250381814628 ()
30-748-15

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable
No Description
IT-V Medizintechnik GmbH
P10107-513
In Commercial Distribution

  • 09120074395138 ()


  • Radiological whole-body positioner
No Description
OSADA ELECTRIC CO.,LTD.
Plugger set#15
In Commercial Distribution

  • 04582227397072 ()
81901

  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
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