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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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ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S 4.5 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
A6-6545-S
In Commercial Distribution

  • 00858816006033 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices 5.0 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
A6-6550-S
In Commercial Distribution

  • 00858816006026 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
RA6-6565-S
In Commercial Distribution

  • 00858816006019 ()


  • Tendon/ligament bone anchor, bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S 5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
RA6-6550-S
In Commercial Distribution

  • 00858816006002 ()


  • Tendon/ligament bone anchor, bioabsorbable
Maxilla Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759460 ()
GCMAXTI

  • Custom-made orthopaedic/craniofacial surgical guide
Mandible Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759453 ()
GCMANTI

  • Custom-made orthopaedic/craniofacial surgical guide
Fibula cutting guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759446 ()
GCPTI

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759422 ()
FPCOD

  • Custom-made orthopaedic/craniofacial surgical guide
Interm Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759415 ()
FICOD

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759408 ()
FFCOD

  • Custom-made orthopaedic/craniofacial surgical guide
Condyle Position Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469285 ()
CGPTI

  • Custom-made orthopaedic/craniofacial surgical guide
Guide anchor screws with dental support Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469278 ()
GASDSTI

  • Custom-made orthopaedic/craniofacial surgical guide
BSSO Surgical Guide with Dental Support - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469261 ()
GCSDTI

  • Custom-made orthopaedic/craniofacial surgical guide
BSSO Surgical Guide - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469230 ()
GCSTI

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthognathic Surgical Splint - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469223 ()
FPCOBC

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthognathic Surgical Splint - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469216 ()
FPCOTI

  • Custom-made orthopaedic/craniofacial surgical guide
Screw metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801680 ()
Q-SPTS

  • Custom-made orthopaedic/craniofacial surgical guide
Slot metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801673 ()
Q-SPCS

  • Custom-made orthopaedic/craniofacial surgical guide
Drill metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801666 ()
Q-SPBS

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801659 ()
GCGTI

  • Custom-made orthopaedic/craniofacial surgical guide
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