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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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Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543463 ()
GCLRBC

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

  • 00860007543456 ()
FFCOBC

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

  • 00860007543449 ()
FICOBC

  • Custom-made orthopaedic/craniofacial surgical guide
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
Seneca Devices, Inc.
EAS-42-Z
In Commercial Distribution

  • 00860004936817 ()


  • Bed mattress support platform, hydraulic
  • Intensive-care patient transport system, ventilatory support, neonatal
SEEG ANCHOR BOLT DRIVER, 235MM LENGTH FOR 2.1MM DRILL
PMT CORPORATION
2103-204
In Commercial Distribution

  • 00650551148784 ()


  • Neurological stereotactic surgery system
SEEG DEPTH ANCHOR BOLT DRIVER WITH MEDIUM WELL SOCKET FOR 2.4MM DRILL
PMT CORPORATION
2103-144
In Commercial Distribution

  • 00650551147503 ()


  • Neurological stereotactic surgery system
BUSHING FOR 2.4MM DRIVER FOR NEUROMATE
PMT CORPORATION
2103-183
In Commercial Distribution

  • 00650551147480 ()


  • Neurological stereotactic surgery system
RULER, WITH SAME DIAMETER AS sEEG DRIVER, FOR 2.1MM DIAMETER DRILL BIT
PMT CORPORATION
2103-125
In Commercial Distribution

  • 00650551146391 ()
2103-125

  • Neurological stereotactic surgery system
VERTEK BUSHING FOR 2.4MM DRILL/DRIVER W/THUMBSCREW
PMT CORPORATION
2103-154
In Commercial Distribution

  • 00650551137580 ()


  • Neurological stereotactic surgery system
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