1-4 MV ISORAD Detector (3m Cable) 11620003Z

GUDID B01611620003Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe

• Primary Device ID: B01611620003Z0
• NIH Device Record Key: 8a5eb46c-e6e8-419c-a568-8275a6f860f8
• Commercial Distribution Discontinuation: 2019-06-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 1-4 MV ISORAD Detector (3m Cable)
• Version Model Number: 11620003Z
• Catalog Number: 11620003Z
• 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 *When shipping a detector, always pack in a shipping container designed for fragile objects.
• Special Storage Condition, Specify: Between 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
• Special Storage Condition, Specify: Between 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
• Special Storage Condition, Specify: Between 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
• Special Storage Condition, Specify: Between 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
• Special Storage Condition, Specify: Between 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
• Special Storage Condition, Specify: Between 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
• Special Storage Condition, Specify: Between 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
• Special Storage Condition, Specify: Between 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
• Special Storage Condition, Specify: Between 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880539 [Primary]
HIBCC	B01611620003Z0 [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 [1-4 MV ISORAD Detector (3m Cable)]

• B01611620003Z0: Radiation therapy QA device.
• B01611620002Z0: Radiation therapy QA device.