Clarity®

GUDID 07540180000214

Clarity® TPUS Autoscan Position Kit

Elekta Ltd

Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system
Primary Device ID07540180000214
NIH Device Record Keyfc5f89e7-dfad-4f39-8b74-c34c32b9b6e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarity®
Version Model Number9100-00062
Company DUNS248858511
Company NameElekta Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com
Phone+1(855)693-5358
Emailclarity.support@elekta.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540180000214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWBSystem, radiation therapy, radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-04
Device Publish Date2019-03-27

On-Brand Devices [Clarity®]

07540180000207Clarity® Software
07540180000191Description
07540180000184Clarity® Software
07540180000177Clarity® QA Phantom
07540180000160Clarity® Calibration & QA Phantom
07540180000153Clarity® CPI, Rail-less
07540180000146Clarity® CPI, Railed
07540180000139Clarity® Optical Tracking System
07540180000122Clarity® Remote Control
07540180000115Clarity® TPUS Autoscan Probe Base Kit
07540180000108Clarity® Digitizer
07540180000092Clarity® TPUS Autoscan Probe (m4DC7-3/40) - Refurbished
07540180000085Clarity® TPUS Autoscan Probe (m4DC7-3/40)
07540180000078Clarity® Linear Probe (L14-5W/60) - Refurbished
07540180000061Clarity® Linear Probe (L14-5W/60)
07540180000054Clarity® Curved Probe (C5-2/60) - Refurbished
07540180000047Clarity® Curved Probe (C5-2/60)
07540180000030Clarity® Acquisition Station (310C00) - Refurbished
07540180000023Clarity® Acquisition Station (310C00)
07540180000016Clarity® System 310C00
07540180000214Clarity® TPUS Autoscan Position Kit
07540180000238Clarity® Optical Tracking System

Trademark Results [Clarity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLARITY
CLARITY
98449573 not registered Live/Pending
A & A Drug Co.
2024-03-14
CLARITY
CLARITY
98405327 not registered Live/Pending
Pitney Bowes Inc.
2024-02-14
CLARITY
CLARITY
98352796 not registered Live/Pending
Precision Planting LLC
2024-01-11
CLARITY
CLARITY
98260471 not registered Live/Pending
Quorum Cyber Security Limited
2023-11-08
CLARITY
CLARITY
98260047 not registered Live/Pending
Fuelling, Adam D
2023-11-08
CLARITY
CLARITY
98258687 not registered Live/Pending
Magi, Inc.
2023-11-07
CLARITY
CLARITY
98258327 not registered Live/Pending
Ceribell, Inc.
2023-11-07
CLARITY
CLARITY
98248197 not registered Live/Pending
Motaharian, Houman
2023-10-31
CLARITY
CLARITY
98179955 not registered Live/Pending
Diamond Mattress Company, Inc.
2023-09-14
CLARITY
CLARITY
98163798 not registered Live/Pending
INQUIRY HEALTH LLC
2023-09-04
CLARITY
CLARITY
98077701 not registered Live/Pending
AGM CONTAINER CONTROLS, INC.
2023-07-10
CLARITY
CLARITY
98047016 not registered Live/Pending
Symmons Industries, Inc.
2023-06-16

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