AccessGUDID - DEVICE: 3D Reservoir (05060608880331)

GUDID

Device Identifier (DI) Information

Brand Name: 3D Reservoir
Version or Model: 1230890Z
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12300002Z
Company Name: SUN NUCLEAR CORP.

Primary DI Number: 05060608880331
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122240021 *Terms of Use
Previous DI: B01612300002Z0

Device Description: Accessory to the 1230 3D SCANNER.

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 [?]
K101992	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: Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: Do not store equipment on top of the 3D Reservoir.
Special Storage Condition, Specify: Do not store equipment inside the 3D Reservoir.
Special Storage Condition, Specify: Never expose the electronics portion of the 3D Reservoir to the beam, including where it could be exposed during rotation.
Special Storage Condition, Specify: Never store the 3D Reservoir where it can accidentally be irradiated.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c7cf59b9-667c-407f-b9d2-3685c1ae5645
Public Version Date: April 26, 2019
Public Version Number: 1
DI Record Publish Date: April 18, 2019