Home GUDID 00815351021778 C-Fuse® Cervical Intervertebral Body Fusion System
Primary DI 00815351021778
Brand C-Fuse® Cervical Intervertebral Body Fusion System
Company Southern Spine LLC
Model MA-665
Device description Mallet
Published 2016-07-20
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 ODP Intervertebral fusion device with bone graft, cervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815351021778 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 00815351021778 00815351021778 815351021778 0815351021778
GMDN Terms# Term, Definition table Term Definition Surgical mallet A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 794672225 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 00815351022683 Deploy™ Expandable Interbody System DT-1244 2022-01-10 00815351020009 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 1021 2015-10-16 00815351020016 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 1024 2015-10-16 00815351020023 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 1027 2015-10-16 00815351020030 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 1030 2015-10-16 00815351020047 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 1033 2015-10-16 00815351020054 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 2036 2015-10-16 00815351020061 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 2039 2015-10-16 00815351020078 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 2042 2015-10-16 00815351020085 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 2045 2015-10-16 00815351020092 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 2048 2015-10-16 00815351020108 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 3054 2015-10-16 00815351020115 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 3058 2015-10-16 00815351020122 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 3062 2015-10-16 00815351020139 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 3066 2015-10-16 00815351020146 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 3070 2015-10-16 00815351020153 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 4072 2015-10-16 00815351020160 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 4076 2015-10-16 00815351020177 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 4080 2015-10-16 00815351020184 Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System 4084 2015-10-16
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