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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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No Description
SMART DENTURE CONVERSIONS, LLC
23ZIH45-OA
In Commercial Distribution

  • D99023ZIH45OA0 ()


  • Dental implant suprastructure, permanent, preformed
No Description
SMART DENTURE CONVERSIONS, LLC
23ZIH35-OA
In Commercial Distribution

  • D99023ZIH35OA0 ()


  • Dental implant suprastructure, permanent, preformed
Integra® Ti6® The threaded guide wire is used as a guide for placement or insertion of a device. It is used with the Ti6 TC-Series.
Ascension Orthopedics, Inc.
KW1102P
Not in Commercial Distribution

  • M269KW1102P1 ()
  • 10381780245896 ()

  • 3.94in L x .035in diameter
KW1102P

  • Orthopaedic guidewire, reusable
Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 3.0 and 4.0mm screws.
Ascension Orthopedics, Inc.
FS2060
In Commercial Distribution

  • M269FS20601 ()
  • 10381780245056 ()

  • 3.516 in L
FS2060

  • Surgical drill guide, reusable
Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 2.0 and 2.5mm screws.
Ascension Orthopedics, Inc.
FS2050
In Commercial Distribution

  • M269FS20501 ()
  • 10381780245049 ()

  • 3.074 in L
FS2050

  • Surgical drill guide, reusable
Integra® Ti6® The TS-Series depth gauge for 3.0/4.0 mm screws is a tool used to measure the depth of a drilled hole.
Ascension Orthopedics, Inc.
FS2040
In Commercial Distribution

  • M269FS20401 ()
  • 10381780245032 ()

  • 1.87 in L probe
FS2040

  • Surgical depth gauge, reusable
Integra® Ti6® The TS-Series depth gauge for 2.0/2.5 mm screws is a tool used to measure the depth of a drilled hole.
Ascension Orthopedics, Inc.
FS2030
In Commercial Distribution

  • M269FS20301 ()
  • 10381780245025 ()

  • 2.074 in L probe
FS2030

  • Surgical depth gauge, reusable
Integra® Ti6® The smooth guide wire is used as a guide for placement or insertion of a device. This guide wire has a double point.
Ascension Orthopedics, Inc.
DW1111
In Commercial Distribution

  • M269DW11111 ()
  • 10381780244837 ()

  • 90 mm L x .838 mm dia
DW1111

  • Orthopaedic guidewire, reusable
Integra® Ti6® The combination Countersink and Depth Gauge allows for precise measurement. This tool is used with the Ti6 Digital Screw.
Ascension Orthopedics, Inc.
DS1008
In Commercial Distribution

  • M269DS10081 ()
  • 10381780244776 ()

  • 3.42 in L x .112 in center dia tip
DS1008

  • Surgical depth gauge, reusable
Integra® Ti6® The ratchet handle is used in conjunction with the Digital Fusion screws.
Ascension Orthopedics, Inc.
DS1007
In Commercial Distribution

  • M269DS10071 ()
  • 10381780244769 ()

  • 5.92 in L
DS1007

  • Surgical instrument handle, non-torque-limiting
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