Trinias

GUDID 04540217064762

SHIMADZU CORPORATION

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• Primary Device ID: 04540217064762
• NIH Device Record Key: 3e202404-3071-4f28-bb84-eef67777c1a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinias
• Version Model Number: 503-79832-44
• 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: true
• 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	04540217064762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123508

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

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: 2020-09-30
• Device Publish Date: 2020-09-22

On-Brand Devices [Trinias]

• 04540217058792: 503-79840-31
• 04540217058754: 503-79841-31
• 04540217058716: 503-79832-32
• 04540217058709: 503-79832-31
• 04540217058631: 503-79833-32
• 04540217058624: 503-79833-31
• 04540217058365: 503-79823-31
• 04540217058327: 503-79822-31
• 04540217058280: 503-79831-33
• 04540217058273: 503-79831-32
• 04540217058266: 503-79831-31
• 04540217058167: 503-79821-33
• 04540217058150: 503-79821-32
• 04540217058143: 503-79821-31
• 04540217058044: 503-79830-33
• 04540217058037: 503-79830-32
• 04540217058020: 503-79830-31
• 04540217057924: 503-79820-33
• 04540217057917: 503-79820-32
• 04540217057900: 503-79820-31
• 04540217049080: 503-79402-33
• 04540217049073: 503-79402-32
• 04540217049066: 503-79402-31
• 04540217048939: 503-79401-33
• 04540217048922: 503-79401-32
• 04540217048915: 503-79401-31
• 04540217064762: 503-79832-44
• 04540217064021: 503-79416-03
• 04540217063253: 503-79864-47
• 04540217063222: 503-79864-27
• 04540217063192: 503-79864-07
• 04540217063161: 503-79863-48
• 04540217063154: 503-79863-47
• 04540217063109: 503-79863-28
• 04540217063093: 503-79863-27
• 04540217063048: 503-79863-08
• 04540217063031: 503-79863-07
• 04540217062980: 503-79861-48
• 04540217062973: 503-79861-47
• 04540217062928: 503-79861-28
• 04540217062911: 503-79861-27
• 04540217062867: 503-79861-08
• 04540217062850: 503-79861-07
• 04540217067152: 563-79864-47
• 04540217067145: 563-79864-27
• 04540217067138: 563-79864-07
• 04540217067121: 563-79863-99
• 04540217067114: 563-79863-89
• 04540217067107: 563-79863-79
• 04540217067091: 563-79863-49