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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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Restore is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
GOOD CLEAN LOVE, INC.
2 oz
In Commercial Distribution

  • 30850014621477 ()
  • 00850014621476 ()
900300

  • General-body orifice lubricant, non-sterile
Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)
SIRTEX MEDICAL PTY LTD
SIR-K002
In Commercial Distribution

  • 00850014612092 ()


  • General-purpose brachytherapy system applicator, manual
SIR-Spheres Syringe Shield
SIRTEX MEDICAL PTY LTD
SIR-S001
In Commercial Distribution

  • 00850014612085 ()


  • Syringe radiation shield
SIR-Spheres V-Vial Holder
SIRTEX MEDICAL PTY LTD
SIR-H001
In Commercial Distribution

  • 00850014612078 ()


  • Vial radiation shield
SIR-Spheres V-Vial
SIRTEX MEDICAL PTY LTD
SIR-V001
In Commercial Distribution

  • 00850014612061 ()


  • General-purpose brachytherapy system applicator, manual
Sir-Spheres delivery set
SIRTEX MEDICAL PTY LTD
SIR-D001
In Commercial Distribution

  • 00850014612054 ()


  • General-purpose brachytherapy system applicator, manual
Delivery Apparatus for the administration of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-B001
In Commercial Distribution

  • 00850014612047 ()


  • Radiation shielding container, general-purpose
Sterile disposable tubing designed to provide proper routing of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-10300
In Commercial Distribution

  • 00850014612023 ()
SIR-10300

  • General-purpose brachytherapy system applicator, manual
Set for the preparation of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-10200
In Commercial Distribution

  • 00850014612016 ()
SIR-10200

  • General-purpose brachytherapy system applicator, manual
  • Vial radiation shield
Delivery Dome for the administration of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-10100
In Commercial Distribution

  • 00850014612009 ()
SIR-10100

  • Radiation shielding container, general-purpose
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