Catheter Transfer Guide Tube with integrated Channel 19 Quick Connect GM19003190

GUDID 00816389026872

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube Brachytherapy system remote afterloading source transfer tube Brachytherapy system remote afterloading source transfer tube

• Primary Device ID: 00816389026872
• NIH Device Record Key: 817ac8ff-4f7c-4d69-a4ff-b6cc820405a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catheter Transfer Guide Tube with integrated Channel 19 Quick Connect
• Version Model Number: GM19003190
• Catalog Number: GM19003190
• 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: 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	00816389026872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113766

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: 2016-09-19

Devices Manufactured by Varian Medical Systems Deutschland GmbH

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• 10816389027210 - Sterilization plug, black (pack of 25): 2024-05-03
• 10816389024646 - Flexible implant tube, double leader, 530 mm, sterile, set of 3: 2024-04-19
• 10816389020310 - Transfer Guide Tube + for 320 mm applicators: 2024-02-28
• 10816389020327 - Transfer Guide Tube + of 1000 mm length for applicators: 2024-02-28
• 10816389020334 - Transfer Guide Tube + for 200 mm catheters: 2024-02-28
• 00816389020344 - Transfer Guide Tube + for 250 mm catheters: 2024-02-28
• 10816389020358 - Transfer Guide Tube + of 500 mm length for catheters: 2024-02-28