3D Reservoir 12300002Z

GUDID B01612300002Z0

Accessory to the 1230 3D SCANNER.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: B01612300002Z0
• NIH Device Record Key: 92e94436-9b94-49f6-a9de-e53371691a0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Reservoir
• Version Model Number: 12300002Z
• Catalog Number: 12300002Z
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Never store the 3D Reservoir where it can accidentally be irradiated.
• Special Storage Condition, Specify: Between 0 and 0 *Never expose the electronics portion of the 3D Reservoir to the beam, including where it could be exposed during rotation.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store equipment inside the 3D Reservoir.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store equipment on top of the 3D Reservoir.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the 3D Reservoir where it can accidentally be irradiated.
• Special Storage Condition, Specify: Between 0 and 0 *Never expose the electronics portion of the 3D Reservoir to the beam, including where it could be exposed during rotation.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store equipment inside the 3D Reservoir.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store equipment on top of the 3D Reservoir.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B01612300002Z0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101992

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-14

On-Brand Devices [3D Reservoir]

• B01612300002Z0: Accessory to the 1230 3D SCANNER.
• 05060608880331: Accessory to the 1230 3D SCANNER.