Home GUDID M69632400P1 OIC Pedicle Screw System
Primary DI M69632400P1
Brand OIC Pedicle Screw System
Company ORTHOPAEDIC IMPLANT COMPANY, THE
Model 32-400P
Device description CALIBRATED GUIDE PIN 3.2MM X 400MM
Published 2017-02-01
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MNI Orthosis, Spinal Pedicle Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M69632400P1 Primary HIBCC 0 M69632400P0 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone pin, non-bioabsorbable A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 070061160 Device count 5 Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10811998032150 OIC Cannulated Screw System 01-SHS10 2018-07-31 10811998036301 OIC Intramedullary Nail System 01-IM30 2018-07-31 10811998036325 OIC Intramedullary Nail System 01-IM32 2018-07-31 10811998036349 OIC Intramedullary Nail System 01-IM34 2018-07-31 10811998036387 OIC Intramedullary Nail System 01-IM40 2018-07-31 10811998036394 OIC Intramedullary Nail System 01-IM41 2018-07-31 10811998036561 OIC Intramedullary Nail System 01-IM58 2018-08-07 10811998038022 OIC Intramedullary Nail System 01-IMSE03 2018-08-07 10811998038039 OIC Intramedullary Nail System 01-IMSE04 2018-08-07 M69601IM300 OIC Intramedullary Nail System 01-IM30 2017-02-01 M69601IM320 OIC Intramedullary Nail System 01-IM32 2017-02-01 M69601IM340 OIC Intramedullary Nail System 01-IM34 2017-02-01 M69601IM400 OIC Intramedullary Nail System 01-IM40 2017-02-01 M69601IM410 OIC Intramedullary Nail System 01-IM41 2017-02-01 M69601SHS100 OIC Cannulated Screw System 01-SHS10 2017-02-01 10811998039555 OIC Variable Angle Small Fragment Locking Plate System 01-SF27 2023-09-06 10811998033478 OIC Variable Angle Small Fragment Locking Plate System 01-SF11 2018-07-31 10811998033485 OIC Variable Angle Small Fragment Locking Plate System 01-SF12 2018-07-31 M69601SF110 OIC Variable Angle Small Fragment Locking Plate System 01-SF11 2017-02-01 M69601SF120 OIC Variable Angle Small Fragment Locking Plate System 01-SF12 2017-02-01
Other Devices Sharing Product Codes# 
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