AccessGUDID - DEVICE: IVD 2 (05060608880058)

GUDID

Device Identifier (DI) Information

Brand Name: IVD 2
Version or Model: 1137000-0Z
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1137000-0Z
Company Name: SUN NUCLEAR CORP.

Primary DI Number: 05060608880058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122240021 *Terms of Use
Previous DI: B01611370000Z0

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
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011332	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
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -30 and 50 Degrees Celsius
Special Storage Condition, Specify: Store the IVD system components in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation is kept at a minimum.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 297f9f1a-e593-45b4-b3f2-92ea4a06c1f9
Public Version Date: October 09, 2019
Public Version Number: 1
DI Record Publish Date: October 01, 2019