Home GUDID 11110991 SAMBA SCREW SYSTEM
Primary DI 11110991
Brand SAMBA SCREW SYSTEM
Company MEDICAL DESIGNS LLC
Model 11-1109-FD9-1
Device description Drill Bit
Published 2016-09-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OUR Sacroiliac Joint Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OUR Sacroiliac Joint Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 11110991 Direct Marking HIBCC 0 M364111109FD910 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Sacroiliac joint transarticular fixation/arthrodesis implantation kit A collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 003815548 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M364111106FD1220 Asfora Anterior Cervical Plate System 11-1106-FD1-22 2016-09-27 M364111106FD1240 Asfora Anterior Cervical Plate System 11-1106-FD1-24 2016-09-27 M364111106FD1260 Asfora Anterior Cervical Plate System 11-1106-FD1-26 2016-09-27 M364111106FD1280 Asfora Anterior Cervical Plate System 11-1106-FD1-28 2016-09-27 M364111106FD1300 Asfora Anterior Cervical Plate System 11-1106-FD1-30 2016-09-27 M364111106FD1320 Asfora Anterior Cervical Plate System 11-1106-FD1-32 2016-09-27 M364111106FD1340 Asfora Anterior Cervical Plate System 11-1106-FD1-34 2016-09-27 M364111106FD2320 Asfora Anterior Cervical Plate System 11-1106-FD2-32 2016-09-27 M364111106FD2350 Asfora Anterior Cervical Plate System 11-1106-FD2-35 2016-09-27 M364111106FD2380 Asfora Anterior Cervical Plate System 11-1106-FD2-38 2016-09-27 M364111106FD2410 Asfora Anterior Cervical Plate System 11-1106-FD2-41 2016-09-27 M364111106FD2440 Asfora Anterior Cervical Plate System 11-1106-FD2-44 2016-09-27 M364111106FD2470 Asfora Anterior Cervical Plate System 11-1106-FD2-47 2016-09-27 M364111106FD2500 Asfora Anterior Cervical Plate System 11-1106-FD2-50 2016-09-27 M364111106FD350 Asfora Anterior Cervical Plate System 11-1106-FD35 2016-09-27 M364111106FD3510 Asfora Anterior Cervical Plate System 11-1106-FD3-51 2016-09-27 M364111106FD3540 Asfora Anterior Cervical Plate System 11-1106-FD3-54 2016-09-27 M364111106FD3570 Asfora Anterior Cervical Plate System 11-1106-FD3-57 2016-09-27 M364111106FD3600 Asfora Anterior Cervical Plate System 11-1106-FD3-60 2016-09-27 M364111106FD3630 Asfora Anterior Cervical Plate System 11-1106-FD3-63 2016-09-27
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