Tool for vaginal cylinders GM11002800

GUDID 00816389022324

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389022324
• NIH Device Record Key: 9664592b-f29d-4205-822c-77090516a245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tool for vaginal cylinders
• Version Model Number: GM11002800
• Catalog Number: GM11002800
• 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: 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	00816389022324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033371

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: 2016-09-22

Devices Manufactured by Varian Medical Systems Deutschland GmbH

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• 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
• 20816389020362 - Transfer Guide Tube + of 1000 mm length for catheters: 2024-02-28
• 10816389020372 - Transfer Guide Tube + of 1000 mm length for Luer connections: 2024-02-28