Fixation buttons, pack of 10, sterile GM11010380

GUDID 30816389027290

VARIAN MEDICAL SYSTEMS, INC.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 30816389027290
• NIH Device Record Key: c2f4e0b7-e9e4-42e3-a1f8-dd020bdd22ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixation buttons, pack of 10, sterile
• Version Model Number: GM11010380
• Catalog Number: GM11010380
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00816389027299 [Unit of Use]
GS1	20816389027293 [Primary]
GS1	30816389027290 [Package]; Contains: 20816389027293; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241965

FDA Product Code

• JAQ: System, Applicator, Radionuclide, Remote-Controlled

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-21
• Device Publish Date: 2025-02-13

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 30816389027290 - Fixation buttons, pack of 10, sterile: 2025-02-21
• 30816389027290 - Fixation buttons, pack of 10, sterile: 2025-02-21
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• 00850800006074 - Vitesee: 2024-11-11
• 00858086006467 - Varian Collimator Accessories 30 CM wedge set lower (JITKIT): 2024-10-07
• 00858086006474 - Varian Collimator Accessories 30 CM wedge set upper (JITKIT): 2024-10-07
• 00858086006481 - Varian Collimator Accessories 20 cm wedge set lower: 2024-10-07