AccessGUDID - DEVICE: ArcCHECK (B01612200000Z0)

GUDID

Device Identifier (DI) Information

Brand Name: ArcCHECK
Version or Model: 12200000Z
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 12200000Z
Company Name: SUN NUCLEAR CORP.

Primary DI Number: B01612200000Z0
Issuing Agency: HIBCC
Commercial Distribution End Date: April 15, 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?	MR Unsafe
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 [?]
K131466	000
K142617	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: When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
Special Storage Condition, Specify: When shipping or transporting the ArcCHECK, ensure the shipping temperature and humidity meet the Handling Specifications.
Special Storage Condition, Specify: Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify: Store the ArcCHECK in an indoor, climate-controlled environment.
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 60 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 28d4c7e5-6492-4019-b015-7e9d7127e817
Public Version Date: April 15, 2019
Public Version Number: 5
DI Record Publish Date: January 14, 2017