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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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PCRopsis™ Elution Buffer is intended to elute test material from substrates.
ENTOPSIS, LLC
Elution Buffer
Not in Commercial Distribution

  • B5503585000 ()
358500

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Elution Buffer is intended to elute test material from substrates.
ENTOPSIS, LLC
Elution Buffer
In Commercial Distribution

  • B55035810000 ()
3581000

  • Nucleic acid extraction/isolation kit IVD
OsteoSurge100, 10cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56300100
In Commercial Distribution

  • M386563001001 ()
  • 10889981055820 ()

  • 10cc
56300100

  • Bone matrix implant, human-derived
OsteoSurge100, 5cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56300050
In Commercial Distribution

  • M386563000501 ()
  • 10889981055813 ()

  • 5cc
56300050

  • Bone matrix implant, human-derived
OsteoSurge100, 2.5cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56300025
In Commercial Distribution

  • M386563000251 ()
  • 10889981055806 ()

  • 2.5cc
56300025

  • Bone matrix implant, human-derived
OsteoSurge100, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56300010
In Commercial Distribution

  • M386563000101 ()
  • 10889981055790 ()

  • 1cc
56300010

  • Bone matrix implant, human-derived
The device RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The device is accessory to the Cube 4D Navigation system.
Fiagon GmbH
E012003
In Commercial Distribution

E012003

  • Multi-purpose stereotactic surgery system
80011 is a multipack of 20 oxygen stem connectors (off-the-shelf). - 1: (61911) Connector, Straight, 22M-6mm Oxygen Stem The component is part of the LungFit PH verification kit.
Beyond Air, Inc.
80011
In Commercial Distribution

  • B882800112 ()
  • B882800111 ()


  • Nitric oxide delivery unit, system-based
Rely•a•Bond® is intended for use in bonding metal, composite andceramic orthodontic brackets. This is a 8g bottle of Rely A Bond primer with fluoride
RELIANCE ORTHODONTIC PRODUCTS INC
BIRPRF8GM
In Commercial Distribution

  • D798BIRPRF8GM0 ()
BIRPRF8GM

  • Orthodontic bracket adhesive
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. This is a 3.5gm push syringe of Rely A Bond Paste.
RELIANCE ORTHODONTIC PRODUCTS INC
1RPP
In Commercial Distribution

  • D7981RPP0 ()
1RPP

  • Orthodontic bracket adhesive
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