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 Class Implantable

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NOVASTEP
CM010030
Not in Commercial Distribution

  • 03700879509631 ()
CM010030

  • Phalangeal joint arthrodesis implant
Nexis headed screw Ø2,9 Reamer single-use
NOVASTEP
XRE01013D
Not in Commercial Distribution

  • 03700879509587 ()
XRE01013D

  • General internal orthopaedic fixation system implantation kit
Nexis headed screw Ø2,3 Reamer single-use
NOVASTEP
XRE01012D
Not in Commercial Distribution

  • 03700879509570 ()
XRE01012D

  • General internal orthopaedic fixation system implantation kit
Fraise vis headed Ø2,9
NOVASTEP
XRE01013
Not in Commercial Distribution

  • 03700879509563 ()
XRE01013

  • General internal orthopaedic fixation system implantation kit
Single Use Instrumentation Kit - Airlock Utility Trial Implants
NOVASTEP
SUI03004
Not in Commercial Distribution

  • 03700879509549 ()
SUI03004

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Single Use Instrumentation Kit - Airlock Lapidus Trial Implants
NOVASTEP
SUI03003
Not in Commercial Distribution

  • 03700879509532 ()
SUI03003

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Single Use Instrumentation Kit - Airlock MT base Trial Implants
NOVASTEP
SUI03002
Not in Commercial Distribution

  • 03700879509525 ()
SUI03002

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Single Use Instrumentation Kit - Airlock MTP Trial Implants
NOVASTEP
SUI03001
Not in Commercial Distribution

  • 03700879509518 ()
SUI03001

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Fraise vis headed Ø2,3
NOVASTEP
XRE01012
Not in Commercial Distribution

  • 03700879509501 ()
XRE01012

  • General internal orthopaedic fixation system implantation kit
K-Wire Ø2 lg200 TR/RD
NOVASTEP
CKW01007
Not in Commercial Distribution

  • 03700879509495 ()
CKW01007

  • Orthopaedic intraoperative positioning pin, single-use
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