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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 Surearly SMART Menopause Test works by inserting the test stick into the Test reader, which measures color changes on the test stick. It detects FSH at a concentration of 25 mIU/mL or greater. The test line utilizes a monoclonal FSH antibody and the test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, FSH combines with antibody gold conjugates on the gold conjugate pad. The formed antigen-antibody complexes react with the anti-FSH antibody on the test line, resulting in red or purple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, the Surearly SMART Menopause Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graphs and additional messages to help your comprehensive management of hormonal health.
Sugentech Inc._Osong Branch
Surearly SMART Menopause Test
In Commercial Distribution

  • 08809408863475 ()
  • 08809408863512 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.0mm, 16.5mm, 20.0mm 7fr to 5fr Shaft Size x 200cm Catheter Length Distal Injection Port
Telemed Systems
1730
In Commercial Distribution

  • 00813353010172 ()


  • ERCP catheter, balloon, non-electrical, stone-retrieval
Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.0mm, 16.5mm, 20.0mm 7fr to 5fr Shaft Size x 200cm Catheter Length Proximal Injection Port
Telemed Systems
1720
In Commercial Distribution

  • 00813353010165 ()


  • ERCP catheter, balloon, non-electrical, stone-retrieval
Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.5mm, 16.5mm, 20.0mm 7fr Shaft Size x 200cm Catheter Length Distal Injection Port
Telemed Systems
1710
In Commercial Distribution

  • 00813353010158 ()


  • ERCP catheter, balloon, non-electrical, stone-retrieval
Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.5mm, 16.5mm, 20.0mm 7fr Shaft Size x 200cm Catheter Length Stiff Shaft Style with Distal Injection Port
Telemed Systems
1702
In Commercial Distribution

  • 00813353010141 ()


  • ERCP catheter, balloon, non-electrical, stone-retrieval
Biliary Dilator 10mm Diameter x 8cm Length Balloon Dimension 180cm Total Catheter Length
Telemed Systems
1346
In Commercial Distribution

  • 00813353010103 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Biliary Dilator 8mm Diameter x 4cm Length Balloon Dimension 180cm Total Catheter Length
Telemed Systems
1344
In Commercial Distribution

  • 00813353010097 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Biliary Dilator 6mm Diameter x 2cm Length Balloon Dimension 180cm Total Catheter Length
Telemed Systems
1342
In Commercial Distribution

  • 00813353010080 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Topic Skin Adhesive - ExofinMicro .5ml
SOURCEMARK, LLC.
M1206
In Commercial Distribution

  • 00897392002244 ()
  • 10897392002975 ()
  • 20897392004402 ()


  • Skin-approximation adhesive
Topic Skin Adhesive - Exofin 1.0ml
SOURCEMARK, LLC.
M1205
In Commercial Distribution

  • 00897392002237 ()
  • 10897392002968 ()
  • 20897392004396 ()


  • Skin-approximation adhesive
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