6-12 MV ISORAD Detector (3m Cable) 11630002Z

GUDID B01611630002Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe

• Primary Device ID: B01611630002Z0
• NIH Device Record Key: d526a27d-2f1f-4ece-bad3-8826e9853310
• Commercial Distribution Discontinuation: 2019-06-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 6-12 MV ISORAD Detector (3m Cable)
• Version Model Number: 11630002Z
• Catalog Number: 11630002Z
• 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

• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880546 [Primary]
HIBCC	B01611630002Z0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912250

FDA Product Code

• IWB: System, Radiation Therapy, Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-18
• Device Publish Date: 2017-01-14

On-Brand Devices [6-12 MV ISORAD Detector (3m Cable)]

• B01611630003Z0: Radiation therapy QA device.
• B01611630002Z0: Radiation therapy QA device.