AccessGUDID - DEVICE: 6-12 MV ISORAD Detector (3m Cable) (B01611630002Z0)

GUDID

Device Identifier (DI) Information

Brand Name: 6-12 MV ISORAD Detector (3m Cable)
Version or Model: 11630002Z
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11630002Z
Company Name: SUN NUCLEAR CORP.

Primary DI Number: B01611630002Z0
Issuing Agency: HIBCC
Commercial Distribution End Date: June 18, 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?
38336	Solid-state-semiconductor radiation measuring probe	A device covering a variety of radiation detector probe designs incorporating a solid-state semiconductor serving as an ionization chamber. It is used as a component of a survey meter or analytical instrument used for radiation detection and measurement. It is typically used to detect low amounts of radioactivity and its energy discrimination properties allow it to be incorporated in radiation detection, measurement instruments and radiation spectroscopy systems. The composition and impurities in the semiconductor material used determine its energy discrimination capabilities and the kind of radiation (x-ray, gamma ray, high-energy beta particles or neutrons) that can be detected.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWB	System, Radiation Therapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K912250	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 shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, Specify: Store in an indoor, protected environment where the detector will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify: After cleaning, allow the detector, cable and connector to dry thoroughly, and then place in the storage case along with any accessories.
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: d526a27d-2f1f-4ece-bad3-8826e9853310
Public Version Date: June 18, 2019
Public Version Number: 5
DI Record Publish Date: January 14, 2017