Afterloader Basic Device GammaMedplus 3/24, 127V,Series iX GM84000560

GUDID 00816389027329

Varian Medical Systems Deutschland GmbH

Remote-afterloading brachytherapy system Remote-afterloading brachytherapy system Remote-afterloading brachytherapy system

• Primary Device ID: 00816389027329
• NIH Device Record Key: 0ce488d4-64c0-4f3c-8b90-e704454eb6c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Afterloader Basic Device GammaMedplus 3/24, 127V,Series iX
• Version Model Number: GM84000560
• Catalog Number: GM84000560
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• 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	00816389027329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120993

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

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