Precision Cut EBT3 GafChromic™ Film

GUDID 05060608881178

Precision Cut EBT3 GafChromic™ Film

SUN NUCLEAR CORP.

Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen

• Primary Device ID: 05060608881178
• NIH Device Record Key: 241534ad-c657-4676-84ff-ffe60f8f35e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Cut EBT3 GafChromic™ Film
• Version Model Number: 158200
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608881178 [Primary]

FDA Product Code

• IWZ: Film, Radiographic

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: 2024-01-10
• Device Publish Date: 2024-01-02

Devices Manufactured by SUN NUCLEAR CORP.

• 05060608881178 - Precision Cut EBT3 GafChromic™ Film: 2024-01-10Precision Cut EBT3 GafChromic™ Film
• 05060608881178 - Precision Cut EBT3 GafChromic™ Film: 2024-01-10 Precision Cut EBT3 GafChromic™ Film
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• 05060608881130 - SunSCAN 3D: 2023-06-16 The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commis
• 05060608880041 - rf-IVD 2: 2020-08-03 Radiation therapy QA device.
• 05060608880874 - PlanIQ: 2020-08-03 Radiation therapy QA software.
• 05060608880102 - StereoPHAN: 2020-07-31 Radiation therapy, machine QA device
• 05060608880751 - IC PROFILER: 2020-07-31 Radiation therapy QA device.
• 05060608880768 - IC PROFILER-MR: 2020-07-31 Radiation therapy QA device.