AccessGUDID - DEVICE: PROFILER 2 (B01611740000Z0)

GUDID

Device Identifier (DI) Information

Brand Name: PROFILER 2
Version or Model: 11740000Z
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11740000Z
Company Name: SUN NUCLEAR CORP.

Primary DI Number: B01611740000Z0
Issuing Agency: HIBCC
Commercial Distribution End Date: May 23, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 122240021 *Terms of Use

Device Description: Radiation therapy QA device.

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?
38399	Accelerator system quality assurance device	An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063021	000

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
Special Storage Condition, Specify: Keep the electronics out of the beam during concatenation, rotation, and offset.
Special Storage Condition, Specify: Avoid frequent use of thick buildup, which may cause scattered radiation that will damage the electronics.
Special Storage Condition, Specify: Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated.
Special Storage Condition, Specify: Never leave the instrument on the couch during warm-up.
Special Storage Condition, Specify: Never expose the electronics portion of the instrument to the direct beam.
Special Storage Condition, Specify: Store the PROFILER 2 in an indoor, protected environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -30 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c76b84e-9fb3-4ad0-a4af-0bb1490ecc1e
Public Version Date: May 23, 2019
Public Version Number: 5
DI Record Publish Date: January 14, 2017