Home GUDID 00810005110204 OrthoCircle Spine Pedicle Screw System
Primary DI 00810005110204
Brand OrthoCircle Spine Pedicle Screw System
Company OrthoCircle Spine
Model 101.121
Device description Final Torque Handle
Published 2020-04-13
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810005110204 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810005110204 00810005110204 810005110204 0810005110204
GMDN Terms# Term, Definition table Term Definition Surgical instrument handle, torque-limiting A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 040985864 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810005110266 OrthoCircle Spine Pedicle Screw System 101.127 2020-04-13 00810005110273 OrthoCircle Spine Pedicle Screw System 101.128 2020-04-13 00810005110150 OrthoCircle Spine Pedicle Screw System 101.116 2020-04-10 00810005111249 OrthoCircle Spine Pedicle Screw System SSC1.011 2020-03-29 00810005110778 OrthoCircle Spine Pedicle Screw System PR45055.S11 2020-07-21 00810005110792 OrthoCircle Spine Pedicle Screw System PR45050.S11 2020-07-21 00810005110808 OrthoCircle Spine Pedicle Screw System PR45045.S11 2020-07-21 00810005110815 OrthoCircle Spine Pedicle Screw System PR45060.S11 2020-07-21 00810005110822 OrthoCircle Spine Pedicle Screw System PR55020.S11 2020-07-21 00810005110730 OrthoCircle Spine Pedicel Screw System PR45020.S11 2020-07-09 00810005110747 OrthoCircle Spine Pedicle Screw System PR45025.S11 2020-07-09 00810005110754 OrthoCircle Spine Pedicle Screw System PR45030.S11 2020-07-09 00810005110761 OrthoCircle Spine Pedicle Screw System PR45035.S11 2020-07-09 00810005110785 OrthoCircle Spine Pedicle Screw System PR45040.S11 2020-07-09 00810005110471 OrthoCircle Spine Pedicel Screw System PNR55020.S11 2020-05-14 00810005110488 OrthoCircle Spine Pedicle Screw System PNR55025.S11 2020-05-14 00810005110532 OrthoCircle Spine Pedicle Screw System PNR55050.S11 2020-05-14 00810005110549 OrthoCircle Spine Pedicle Screw System PNR55055.S11 2020-05-14 00810005110556 OrthoCircle Spine Pedicle Screw System PNR55060.S11 2020-05-14 00810005110570 OrthoCircle Spine Pedicle Screw System PNR65020.S11 2020-05-14
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