Home GUDID B525CO010 Large U Head Cushions
Primary DI B525CO010
Brand Large U Head Cushions
Company Octostop Inc
Model CO-01
Published 2017-11-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name KXH Cradle, patient, radiologic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KXH Cradle, Patient, Radiologic Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B525CO010 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Radiological whole-body positioner A device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures. It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.
Regulatory Flags# DUNS number 240536946 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B525BO020 Standard Board BO-02 2017-11-16 B525BO030 Large Board BO-03 2017-11-16 B525CO020 Small U Head Cushions CO-02 2017-11-16 B525CO030 L Head and Arm Cushions CO-03 2017-11-16 B525OC010 Octogones OC-01 2017-11-16 B525OC020 Vertical Support OC-02 2017-11-16 B525PA030 Octopaque no Accessories PA-03 2017-11-16 B525PA040 Minipaque PA-04 2017-11-16 B525PA050 Universal Octopaque PA-05 2017-11-16 B525PA060 Universal Octopaque with Vertical Support PA-06 2017-11-16 B525PA070 Universal Octopaque (Large Board) PA-07 2017-11-16 B525ST070 Large Flanel Blanket ST-07 2017-11-16 B525ST080 Small Flanel Blanket ST-08 2017-11-16 B525ST090 Velcro Strap for Octopaque ST-09 2017-11-16 B525ST100 Self-Adhesive Velcro ST-10 2017-11-16 B525ST130 Large Flanel Blanket (Package of 6) ST-13 2017-11-16 B525ST140 Small Flanel Blanket (Package of 6) ST-14 2017-11-16 B525ST160 XL Flanel Blanket ST-16 2017-11-16 B525ST170 Flanel Blanket Small (3) Large (3) ST-17 2017-11-16 B525UM020 Octoroll UM-02 2017-11-16
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