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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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STERILE TRAC SYSTEM 12 PACK - 00841036198138

No Description
BIOMET MICROFIXATION, INC
SP-3092-12
Not in Commercial Distribution

  • 00841036198138 ()
SP-3092-12

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

STERILE TRAC SYSTEM - 00841036194697

No Description
BIOMET MICROFIXATION, INC
SP-3097
Not in Commercial Distribution

  • 00841036194697 ()
SP-3097

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

STERILE TRAC SYSTEM 12 PACK - 00841036194673

No Description
BIOMET MICROFIXATION, INC
SP-3095-12
Not in Commercial Distribution

  • 00841036194673 ()
SP-3095-12

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

STERILE TRAC SYSTEM 12 PACK - 00841036194642

No Description
BIOMET MICROFIXATION, INC
SP-3091-12
Not in Commercial Distribution

  • 00841036194642 ()
SP-3091-12

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

STERILE TRAC SYSTEM - 00841036182588

No Description
BIOMET MICROFIXATION, INC
SP-3092
Not in Commercial Distribution

  • 00841036182588 ()
SP-3092

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

AccelFix Spinal Fixation System - 08800061325843

Poly Axial Screw Ø6.0 , 25mm
L&K BIOMED CO. ,LTD.
8103-6025S
In Commercial Distribution

  • 08800061325843 ()


  • Cannulated surgical drill bit, single-use

PediNail - 00841132197066

THREADED TROCHAR PIN (3.2 MM)
ORTHOPEDIATRICS CORP.
11-1500-001-S
In Commercial Distribution

  • 00841132197066 ()
11-1500-001-S

  • Orthopaedic guidewire, single-use

PediNail - 00841132195543

7.5/9.5 STEPPED ENTRY REAMER
ORTHOPEDIATRICS CORP.
01-1500-0001-S
In Commercial Distribution

  • 00841132195543 ()
01-1500-0001-S

  • Medullary canal orthopaedic reamer shaft

STERILE TRAC SYSTEM 12 PACK - 00841036123925

No Description
BIOMET MICROFIXATION, INC
25-1005-12
Not in Commercial Distribution

  • 00841036123925 ()
25-1005-12

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

STERILE TRAC SYSTEM 12 PACK - 00841036123871

No Description
BIOMET MICROFIXATION, INC
25-1010-12
Not in Commercial Distribution

  • 00841036123871 ()
25-1010-12

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