AccessGUDID - DEVICE: REFERENCE DETECTOR (TNC) (B01610460001Z0)

GUDID

Device Identifier (DI) Information

Brand Name: REFERENCE DETECTOR (TNC)
Version or Model: 10460001Z
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10460001Z
Company Name: SUN NUCLEAR CORP.

Primary DI Number: B01610460001Z0
Issuing Agency: HIBCC
Commercial Distribution End Date:
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
LHO	Instrument, Quality-Assurance, Radiologic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 Atmospheric Pressure: between 57.2 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal
Special Storage Condition, Specify: Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Special Storage Condition, Specify: Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, Specify: Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, Specify: Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, Specify: Store the Reference Detector and cable in the storage case in an indoor, protected environment.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ddfaf69f-b0b0-43af-8628-b86c23892f64
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 06, 2017