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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 Provox LaryTube Sizer Kit is intended for use by the prescribing specialist to determine the size(s) of LaryTube that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing specialist who has read the LaryTube Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryTubes are intended for the sizing procedure only. After the correct size(s) have been determined, new LaryTube(s) shall be given to the patient for use.
Atos Medical AB
7648
In Commercial Distribution

  • 07331791005329 ()
7648

  • Tracheostomy tube, non-reinforced, non-customized, reusable
The Provox LaryButton Sizer Kit is intended for use by the prescribing clinician to determine the size(s) of LaryButton that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing clinician who has read the LaryButton Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryButtons are intended for the sizing procedure only. After the correct size(s) have been determined a new LaryButton(s) shall be prescribed to the patient for actual use.
Atos Medical AB
7690
In Commercial Distribution

  • 07331791002779 ()
7690

  • Tracheostoma button
DEMONSTRATIVE USE ONLY. NOT FOR USE IN PATIENTS OR FOR SALE Asymmetric, Femoral/Tibia 58, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
881501
In Commercial Distribution

  • 15060155712793 ()

  • Asymmetric, Femoral/Tibia 58
881501

  • Orthopaedic cement spacer
DEMONSTRATIVE USE ONLY. NOT FOR USE IN PATIENTS NOT FOR SALE Asymmetric, Femoral/Tibia 65, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
881500
In Commercial Distribution

  • 15060155712786 ()

  • Asymmetric, Femoral/Tibia 65
881500

  • Orthopaedic cement spacer
In 1949, Dr. George Brecher developed a stain called new methylene blue to identify immature erythrocytes (reticulocytes) based upon aggregations of RNA within disintegrating ribosomes. This RNA is at its highest level immediately after enucleation of the cell and continues to decrease until its complete absence in the fully mature erythrocyte. Reticulocytes are so named due to their mesh-like (reticular) network of ribosomal RNA which, after staining, is readily visible with a blue granulofilamentous appearance. The quantitative evaluation of reticulocytes in peripheral blood is an important test used in the assessment of erythropoiesis, bone marrow function, and anemia typing.
RICHARD-ALLAN SCIENTIFIC COMPANY
Reticulocyte Stain
In Commercial Distribution

  • 00673693090469 ()
89029

  • Biological stain IVD
Patient slider board designed for shifting patient from one bed, stretcher, gurney, or OR table to another. Constructed of high density polyethylene which slides easily on most surfaces and is a hard, non-porous surface making it easy to clean and disinfect. Holes along sides make it easy to grasp from any angle and slide patient to new surface. Economical enough to have in every location you may need to shift patients. Hangs easily out of the way, yet nearby with our stainless steel wall rack. Designed to move patients up to 350 lbs. Not treated for anti-static
MID CENTRAL MEDICAL CORP.
MCM122
In Commercial Distribution

  • 10810030860034 ()

  • Length: 72 Inch
  • Width: 22 Inch
  • Depth: 0.1875 Inch
MCM122

  • Patient position turntable
"H&H" Wound Gel (Sterile) is a transparent gel dressing with an amorphous structure, suitable for irregularly shaped wounds. The formulation is designed to achieve isotonicity, allowing the gel to cover the wound bed, providing a moist wound healing environment, and promoting the migration of new epidermal cells. Carboxymethyl cellulose, combined with glycerol and hyaluronic acid, not only helps absorb wound exudate and blood but also forms a moist gel protective layer on the wound bed, providing an optimal moist healing environment while reducing the risk of infection by acting as a barrier to foreign materials.
TRONJEN MEDICAL TECHNOLOGY INC.
WG0030
In Commercial Distribution

  • 04719884331402 ()
  • 04719884331426 ()

  • Total Volume: 30 Milliliter
WG0030

  • Wound hydrogel dressing, non-antimicrobial
Patient slider board designed for shifting patient from one bed, stretcher, gurney, or OR table to another. Constructed of high density polyethylene which slides easily on most surfaces and is a hard, non-porous surface making it easy to clean and disinfect. Holes along sides make it easy to grasp from any angle and slide patient to new surface. Economical enough to have in every location you may need to shift patients. Hangs easily out of the way yet nearby with our stainless steel wall rack. Designed to move patients up to 350 lbs. Not treated for anti-static
MID CENTRAL MEDICAL CORP.
MCM121
In Commercial Distribution

  • 10810030860027 ()

  • Length: 33 Inch
  • Height: 22 Inch
  • Depth: 0.1875 Inch
MCM121

  • Patient position turntable
Nitrocef Matchbook™, chromogenic nitrocefin test for beta lactamase, on paper strip, 10 tests per package New Easy-to-Use MatchBook Format. Hardy Diagnostics now offers a more convenient way of testing ß-lactamase activity in bacteria. The new Nitrocef MatchBook™ is a rapid test that allows you to quickly pick your colonies and perform the test at the same time! Easier and faster than a disk! The rapid Nitrocef test consists of a paper match-stick that is impregnated with the Nitrocefin reagent, which is a chromogenic cephalosporin. This rapid test can yield clinically relevant information earlier than an MIC test. A positive ß-lactamase test can predict resistance to such antibiotics as penicillin, ampicillin, amoxicillin, and other ß-lactamase containing drugs for the following organisms: • Neisseria gonorrhoeae • Haemophilus spp. • Moraxella (Branhamella) catarrhalis • Staphylococcus spp. • Enterococcus spp. • Anaerobes (such as some species of Bacteroides, Porphyromonas, Clostridium, Fusobacterium, Prevotella) The rapid Nitrocef MatchBookTM can be used for all of the above organisms with results in 5 minutes or less, with the exception of some Staphylococcus spp. that may take up to one hour. The ß-lactamase test is preferred to disk diffusion and agar dilution for the detection of plasmid-mediated beta-lactamase resistance in gonococci. Now contains a larger reaction pad.
HARDY DIAGNOSTICS
Z108
Not in Commercial Distribution

  • 00819398027526 ()
  • 00819398028547 ()
Z108

  • Beta-lactamase detection reagent IVD
The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use.
HYLAND LLC
3.0
In Commercial Distribution

  • 00850677007143 ()
PSM3.0

  • Clinical information system web-based application software
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