Basket tube with three centering baskets, sterile, single use GM11008050

GUDID 00816389024472

Varian Medical Systems Deutschland GmbH

Bronchial brachytherapy system applicator, remote-afterloading Bronchial brachytherapy system applicator, remote-afterloading Bronchial brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389024472
• NIH Device Record Key: 1356f58c-26f7-42a6-9e7d-810a26760263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Basket tube with three centering baskets, sterile, single use
• Version Model Number: GM11008050
• Catalog Number: GM11008050
• 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: 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	00816389024472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082653

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: 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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• 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