iRay

GUDID 06975501940114

Cetus 80F01 High-Voltage Generator

iRay Imaging Technology (Haining) Limited

Diagnostic x-ray system generator, stationary

• Primary Device ID: 06975501940114
• NIH Device Record Key: 6c5deee3-bdc9-4ff3-8b44-44776919abdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iRay
• Version Model Number: Cetus 80F01
• Company DUNS: 722762367
• Company Name: iRay Imaging Technology (Haining) Limited
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	06975501940114 [Primary]

FDA Product Code

• IZO: Generator, High-Voltage, X-Ray, Diagnostic

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: 2022-11-08
• Device Publish Date: 2022-10-31

On-Brand Devices [iRay]

• 06975501940244: Cetus 50R09 High-Voltage Generator
• 06975501940237: Cetus 40R09 High-Voltage Generator
• 06975501940220: Cetus 32R09 High-Voltage Generator
• 06975501940213: Cetus 40F03 High-Voltage Generator
• 06975501940206: Cetus 40R03 High-Voltage Generator
• 06975501940190: Cetus 32F03 High-Voltage Generator
• 06975501940183: Cetus 32R03 High-Voltage Generator
• 06975501940176: Cetus 50F02 High-Voltage Generator
• 06975501940169: Cetus 50R02 High-Voltage Generator
• 06975501940152: Cetus 40F02 High-Voltage Generator
• 06975501940145: Cetus 40R02 High-Voltage Generator
• 06975501940138: Cetus 32F02 High-Voltage Generator
• 06975501940121: Cetus 32R02 High-Voltage Generator
• 06975501940114: Cetus 80F01 High-Voltage Generator
• 06975501940107: Cetus 80R01 High-Voltage Generator
• 06975501940091: Cetus 71F01 High-Voltage Generator
• 06975501940084: Cetus 71R01 High-Voltage Generator
• 06975501940077: Cetus 65F01 High-Voltage Generator
• 06975501940060: Cetus 65R01 High-Voltage Generator
• 06975501940053: Cetus 50F01 High-Voltage Generator
• 06975501940046: Cetus 50R01 High-Voltage Generator
• 06975501940039: Cetus 40F01 High-Voltage Generator
• 06975501940022: Cetus 40R01 High-Voltage Generator
• 06975501940015: Cetus 32F01 High-Voltage Generator
• 06975501940008: Cetus 32R01 High-Voltage Generator
• 06975501940282: CRUX RF10