AccessGUDID - DEVICE: Clarity® (07540180000016)

GUDID

Device Identifier (DI) Information

Brand Name: Clarity®
Version or Model: 9500-00004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Elekta Solutions AB

Primary DI Number: 07540180000016
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 353272181 *Terms of Use

Device Description: Clarity® System 310C00

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45446	Ultrasound patient positioning system	An assembly of devices used to locate, with ultrasound, internal soft-tissue anatomy that moves relative to external or bony landmarks, to enable subsequent adjustment of the patient for precise external beam radiation treatment of the target tissue. It typically includes an ultrasound imaging system, computerized workstation(s), optical tracking devices, and dedicated software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWB	System, radiation therapy, radionuclide
KPQ	System, simulation, radiation therapy
IYE	Accelerator, linear, medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 60 and 106 KiloPascal
Storage Environment Temperature: between 4 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3bea3f77-ce74-4b46-840b-a5fdf5c2a662
Public Version Date: January 01, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016