Home GUDID 00850020486007 Clearsight Bolus
Primary DI 00850020486007
Brand Clearsight Bolus
Company CLEARSIGHT RT LLC
Model B-03-18-01
Device description Clearsight Bolus, 0.3cm water equivalent thickness, 0.34cm physical thickness, Clear, 30cm x 30cm, (3) units per package
Published 2022-05-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name IYP Phantom, Anthropomorphic, Nuclear
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IYP Phantom, Anthropomorphic, Nuclear Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850020486004 Primary GS1 0 00850020486007 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850020486004 10850020486004 00850020486007 00850020486007 850020486007 0850020486007
GMDN Terms# Term, Definition table Term Definition Radiation therapy bolus, single-use A pliable, solid, non-sterile material (e.g., firm gel, paraffin, silicone) that has the properties of skin when irradiated and is intended to be applied to the skin to modify radiation dose at the skin surface or depth. It is available in various static thicknesses (e.g., 0.5 to 4.0 cm), which may be cut by the operator, to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 30 Centimeter Width 30 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store flat (not folded) in original packaging in a cool, dry environment.
Regulatory Flags# DUNS number 117523635 Device count 3 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes#