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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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one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in cartridges.
EMD SERONO, INC.
U1222402
Not in Commercial Distribution

  • 04054839025792 ()


  • Empty self-injector, mechanical
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160206 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160077 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160145 ()


  • Glucose monitoring system IVD, home-use
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1826
In Commercial Distribution

  • 09348215024192 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1626
In Commercial Distribution

  • 09348215024185 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1526
In Commercial Distribution

  • 09348215024178 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1426
In Commercial Distribution

  • 09348215024161 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1326
In Commercial Distribution

  • 09348215024154 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1226
In Commercial Distribution

  • 09348215024147 ()


  • Coated femoral stem prosthesis, modular
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