R-300

GUDID 04540217062447

SHIMADZU CORPORATION

Automatic-aperture-control diagnostic x-ray system collimator

• Primary Device ID: 04540217062447
• NIH Device Record Key: f19890d1-4e02-4fd5-a559-4dbec9e4c66b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R-300
• Version Model Number: 566-17970-50
• Company DUNS: 690558747
• Company Name: SHIMADZU CORPORATION
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04540217062447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101039

FDA Product Code

• IZX: Collimator, Manual, 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: 2020-04-13
• Device Publish Date: 2020-04-03

On-Brand Devices [R-300]

• 04540217051939: 566-17970-85
• 04540217051908: 566-17970-05
• 04540217062461: 566-17970-90
• 04540217062454: 566-25407-60
• 04540217062447: 566-17970-50