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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 wedge 15° is used to adjust the orientation of the osteotomy
NEWDEAL
189215ND
Not in Commercial Distribution

  • M248189215ND1 ()
  • 10381780052937 ()

  • 15° medium correction


  • Bone-angle protractor
The wedge 10° is used to adjust the orientation of the osteotomy
NEWDEAL
189210ND
Not in Commercial Distribution

  • M248189210ND1 ()
  • 10381780052920 ()

  • 10° small correction


  • Bone-angle protractor
The conical reamer holder is to be hung on the basis 519910ND.
NEWDEAL
519912ND
Not in Commercial Distribution

  • M248519912ND1 ()
  • 10381780042761 ()


  • Device sterilization/disinfection container, reusable
A2O System Fluid is used for system cleaning during automated osmolality testing
ADVANCED INSTRUMENTS, INC.
200222
In Commercial Distribution

  • 00816068020634 ()
200222

  • Wash/cleaning solution IVD, automated/semi-automated system
The Fin-Lock Drill Guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
DRG-0926-001
In Commercial Distribution

  • M269DRG09260011 ()
  • 10381780258216 ()

  • 1.25 in L x .960 in W


  • Surgical drill guide, reusable
Integra®Surgical Instruments The ratchet t-handle is provided with quick connect.
Ascension Orthopedics, Inc.
NR135004J004
In Commercial Distribution

  • M269NR135004J0041 ()
  • 10381780246343 ()

  • 4.5 in L x 3.88 in W
NR135004-J-004

  • Surgical instrument handle, non-torque-limiting
Ascension® MCP The MCP X-ray template is used for size assessment.
Ascension Orthopedics, Inc.
TMP-100-00
In Commercial Distribution

  • M269TMP100001 ()
  • 10381780247616 ()

  • NA
TMP-100-00

  • Surgical implant template, reusable
Integra®Surgical Instruments The slap hammer is used to apply force.
Ascension Orthopedics, Inc.
SLP1002519
In Commercial Distribution

  • M269SLP10025191 ()
  • 10381780247463 ()

  • 290 mm L
SLP-1002-519

  • Orthopaedic implant impactor, reusable
Titan™ Reverse Shoulder System The handle is used to remove glenospheres.
Ascension Orthopedics, Inc.
HDL096006701
In Commercial Distribution

  • M269HDL0960067011 ()
  • 10381780245476 ()

  • 10.4 in x .255in diameter
HDL-0960-067-01

  • Surgical instrument handle, non-torque-limiting
Integra® Lunate The Lunate Base is designed to contain the instruments.
Ascension Orthopedics, Inc.
CSA71002
In Commercial Distribution

  • M269CSA710021 ()
  • 10381780243991 ()
CSA-710-02

  • Instrument tray, reusable
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