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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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MIS Precision Chevron Bunion System - 00860005968800

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 - 00860004936817

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

Assembly Required Distributors Inc. - 00860004575627

Doctor Stool Replacement Rubber Tip
Assembly Required Distributors Inc
CHM8908-01
In Commercial Distribution

  • 00860004575627 ()


  • Walking aid tip

Medtronic Reusable Instruments - 00673978069173

INSTRUMENT 875-090 DSTRACTOR SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
875-090
In Commercial Distribution

  • 00673978069173 ()


  • Orthopaedic implant driver

N/A - 00673978067728

INSTRUMENT 873-009 UCS CANN SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
873-009
In Commercial Distribution

  • 00673978067728 ()


  • Surgical screwdriver, reusable

N/A - 00673978064840

INSTR 8616021 NUT & SCRWDRVR SHF COLO II
MEDTRONIC SOFAMOR DANEK, INC.
8616021
In Commercial Distribution

  • 00673978064840 ()


  • Orthopaedic implant driver

N/A - 00673978064673

INSTRUMENT 8616004 SHAFT PEDICULAR SCRDR
MEDTRONIC SOFAMOR DANEK, INC.
8616004
In Commercial Distribution

  • 00673978064673 ()


  • Surgical screwdriver, reusable

N/A - 00673978064628

INST 8616001 DUALPURPOSE NUTDRVR COLO II
MEDTRONIC SOFAMOR DANEK, INC.
8616001
In Commercial Distribution

  • 00673978064628 ()


  • Orthopaedic implant driver

N/A - 00673978063010

M8 INST 858-950 5.5 M8 FXD SCDR .25IN
MEDTRONIC SOFAMOR DANEK, INC.
858-950
In Commercial Distribution

  • 00673978063010 ()

  • 5.5mm


  • Surgical screwdriver, reusable

N/A - 00673978059143

INSTRUMENT 848-929 T25 TRQ LMTING DRVR
MEDTRONIC SOFAMOR DANEK, INC.
848-929
In Commercial Distribution

  • 00673978059143 ()


  • Surgical screwdriver, reusable

N/A - 00673978059136

INSTRUMENT 848-928 PLG CPTRING T25 DRVR
MEDTRONIC SOFAMOR DANEK, INC.
848-928
In Commercial Distribution

  • 00673978059136 ()


  • Surgical screwdriver, reusable

N/A - 00673978059129

INSTRUMENT 848-927 SOLID T25 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
848-927
In Commercial Distribution

  • 00673978059129 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00673978058535

INSTRUMENT 84693E PLUG NUT STARTER
MEDTRONIC SOFAMOR DANEK, INC.
84693E
In Commercial Distribution

  • 00673978058535 ()


  • Orthopaedic implant driver

N/A - 00673978058528

INSTRUMENT 84692E PLUG DTT STARTER
MEDTRONIC SOFAMOR DANEK, INC.
84692E
In Commercial Distribution

  • 00673978058528 ()


  • Orthopaedic implant driver

N/A - 00673978058498

INSTRUMENT 84687E PROVSNL PLUG DRVR
MEDTRONIC SOFAMOR DANEK, INC.
84687E
In Commercial Distribution

  • 00673978058498 ()


  • Surgical screwdriver, reusable

N/A - 00673978058313

INSTRUMENT 84675H T HNDL H REMVL DRVR
MEDTRONIC SOFAMOR DANEK, INC.
84675H
In Commercial Distribution

  • 00673978058313 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00673978058238

INSTRUMENT 84659 CD ILIO SAC SCRWDR CAN
MEDTRONIC SOFAMOR DANEK, INC.
84659
In Commercial Distribution

  • 00673978058238 ()


  • Orthopaedic implant driver

N/A - 00673978050546

INSTR 836-023 732 SOCKET DRVR SHAFT 3D
MEDTRONIC SOFAMOR DANEK, INC.
836-023
In Commercial Distribution

  • 00673978050546 ()

  • 7/32"


  • Surgical screwdriver, reusable

N/A - 00673978050461

INSTRUMENT 836-011 QCK CONN RATCHET HNDL
MEDTRONIC SOFAMOR DANEK, INC.
836-011
In Commercial Distribution

  • 00673978050461 ()


  • Surgical screwdriver, reusable

N/A - 00673978045092

INSTRUMENT 815-518 TORX 25 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
815-518
In Commercial Distribution

  • 00673978045092 ()

  • T-25


  • Surgical screwdriver, reusable
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