Home GUDID 00815351022119 StabiLink®MIS Spinal Fixation System
Primary DI 00815351022119
Brand StabiLink®MIS Spinal Fixation System
Company Southern Spine LLC
Model CR-765
Device description Contouring Rasp, 7mm
Published 2018-09-15
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 KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815351022119 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 00815351022119 00815351022119 815351022119 0815351022119
GMDN Terms# Term, Definition table Term Definition Bone file/rasp, manual A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840606186544 OMEGA XP SPINAL ELEMENTS, INC. KWP 2026-09-22 00840606186551 OMEGA XP SPINAL ELEMENTS, INC. KWP 2026-09-22 10888857598164 Xia® 3 System - Serrato® VB Spine LLC KWP 2026-07-24 10888857598171 Xia® 3 System - Serrato® VB Spine LLC KWP 2026-07-24 10888857598188 Xia® 3 System - Serrato® VB Spine LLC KWP 2026-07-24 10888857598195 Xia® 3 System - Serrato® VB Spine LLC KWP 2026-07-24 10888857598201 Xia® 3 System - Serrato® VB Spine LLC KWP 2026-07-24 10888857598218 Xia® 3 System - Serrato® VB Spine LLC KWP 2026-07-24 10888857598225 Xia® 3 System - Serrato® VB Spine LLC KWP 2026-07-24 10888857598232 Xia® 3 System - Serrato® VB Spine LLC KWP 2026-07-24 10888857598249 Xia® 3 System - Serrato® VB Spine LLC KWP 2026-07-24 00613994738646 ZEPHIR® Anterior Cervical System MEDTRONIC SOFAMOR DANEK, INC. KWP 2019-03-07 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-09-17 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 04546540147257 XIA II Stryker Corporation KWP 2014-12-08 04546540147769 XIA II Stryker Corporation KWP 2014-12-08 04546540147806 XIA II Stryker Corporation KWP 2014-12-08 04546540147905 XIA II Stryker Corporation KWP 2014-12-08 04546540147912 XIA I Stryker Corporation KWP 2014-12-08 04546540147929 XIA I Stryker Corporation KWP 2014-12-08 04546540147936 XIA I Stryker Corporation KWP 2014-12-08 04546540147974 XIA I Stryker Corporation KWP 2014-12-08 04546540147981 XIA I Stryker Corporation KWP 2014-12-08 04546540147998 XIA I Stryker Corporation KWP 2014-12-08 04546540148001 XIA II Stryker Corporation KWP 2014-12-08 04546540148018 XIA II Stryker Corporation KWP 2014-12-08 04546540148025 XIA II Stryker Corporation KWP 2014-12-08
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