Home GUDID 00811801031465 Kodiak
Primary DI 00811801031465
Brand Kodiak
Company ALPHATEC SPINE, INC.
Model CI-10273
Device description Kodiac MIS Reamer
Published 2020-09-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HTO REAMER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTO Reamer Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00811801031465 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 00811801031465 00811801031465 811801031465 0811801031465
GMDN Terms# Term, Definition table Term Definition Bone-resection orthopaedic reamer, reusable An orthopaedic surgical instrument intended to resect bone (cut out part of the bone) and precisely shape a specific area of bone to accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); some types may in addition be designed to be used endoscopically to resect hypertrophic tissue [e.g., ligamentum flavum] to relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 602465783 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840096408690 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408706 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408713 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408720 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408737 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408744 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408751 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408768 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408775 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408782 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408799 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408805 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408812 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408829 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408836 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408843 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408850 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408867 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408874 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408881 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408898 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408904 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408911 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408928 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408935 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408942 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408959 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408966 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408973 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408980 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03
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