Flexible implant tubes, blind-end 350mm, sterile, single use, set of 3 GM11003730

GUDID 10816389022864

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 10816389022864
• NIH Device Record Key: 0f17f8ca-ee74-414e-ab01-332ab8cb626f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible implant tubes, blind-end 350mm, sterile, single use, set of 3
• Version Model Number: GM11003730
• Catalog Number: GM11003730
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 3
• 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 Dimensions

• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter
• Length: 350 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389022867 [Unit of Use]
GS1	10816389022864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172533

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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-06-20
• Device Publish Date: 2016-09-23

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• 00810563022612 - Disassembly Pin, CT/ MR: 2025-05-26
• 00816389029439 - CT/ MR Tandem and Ovoid Set (CTO): 2025-05-26