3D Reservoir 12300002Z

GUDID 05060608880331

Accessory to the 1230 3D SCANNER.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: 05060608880331
• NIH Device Record Key: c7cf59b9-667c-407f-b9d2-3685c1ae5645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Reservoir
• Version Model Number: 1230890Z
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880331 [Primary]
HIBCC	B01612300002Z0 [Previous]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-26
• Device Publish Date: 2019-04-18

On-Brand Devices [3D Reservoir]

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