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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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Opteryx® - M711CI0100

Radel, SST
Innovasis, Inc.
CI-010
In Commercial Distribution

  • M711CI0100 ()
CI-010

  • Orthopaedic implant driver
  • Surgical screwdriver, reusable

C-Box® - M711CCI010

SST
Innovasis, Inc.
CCI-01
In Commercial Distribution

  • M711CCI010 ()
CCI-01

  • Orthopaedic implant driver

Opteryx® - M711CI1100

SST
Innovasis, Inc.
CI-110
In Commercial Distribution

  • M711CI1100 ()
CI-110

  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver

Opteryx® - M711CI0310

SST
Innovasis, Inc.
CI-031
In Commercial Distribution

  • M711CI0310 ()
CI-031

  • Orthopaedic implant driver

Opteryx® - M711CI0300

Radel, SST
Innovasis, Inc.
CI-030
In Commercial Distribution

  • M711CI0300 ()
CI-030

  • Orthopaedic implant driver

Opteryx® - M711CI0120

SST
Innovasis, Inc.
CI-012
In Commercial Distribution

  • M711CI0120 ()
CI-012

  • Orthopaedic implant driver

NA - 10887587071671

90 DEGREE SCREWDRIVER T-HANDLE
Synthes GmbH
SD03.505.005
In Commercial Distribution

  • H980SD035050050 ()
  • 10887587071671 ()
SD03505005

  • Surgical screwdriver, reusable

NA - 10887587066622

2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/6MM BAR
SYNTHES (U.S.A.) LP
SD447.199
Not in Commercial Distribution

  • 10887587066622 ()
  • H980SD4471990 ()
SD447199

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 10887587066615

2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/16MM BAR
SYNTHES (U.S.A.) LP
SD447.204
Not in Commercial Distribution

  • 10887587066615 ()
  • H980SD4472040 ()
SD447204

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 10887587066608

2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/14MM BAR
SYNTHES (U.S.A.) LP
SD447.203
Not in Commercial Distribution

  • 10887587066608 ()
  • H980SD4472030 ()
SD447203

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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