Universal Sterilization Box GM11010340

GUDID 00816389028371

VARIAN MEDICAL SYSTEMS, INC.

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• Primary Device ID: 00816389028371
• NIH Device Record Key: 48d3ef0a-6a50-4fa1-8832-a3ce305e05d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Sterilization Box
• Version Model Number: GM11010340
• Catalog Number: GM11010340
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00816389028371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160021

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

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: 2020-10-05
• Device Publish Date: 2020-09-27

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