R-20J

GUDID 04540217052011

SHIMADZU CORPORATION

Manual-aperture-control diagnostic x-ray system collimator, non-motorized

• Primary Device ID: 04540217052011
• NIH Device Record Key: 10e12d6a-0573-4e3a-b98e-710708a5b95c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R-20J
• Version Model Number: 563-55050-23
• 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	04540217052011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101036

FDA Product Code

• IZX: Collimator, Manual, Radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [R-20J]

• 04540217060115: 563-55050-26
• 04540217059546: 563-55050-32
• 04540217052011: 563-55050-23
• 04540217062416: 563-55050-60
• 04540217062409: 563-55050-50
• 04540217059539: 563-55050-31