Leak Stop Button (pack of 50) GM11003810

GUDID 00816389028326

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389028326
• NIH Device Record Key: dc1df99c-b753-4cb9-ad75-7f0c9ea447c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leak Stop Button (pack of 50)
• Version Model Number: GM11003810
• Catalog Number: GM11003810
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 50
• DM Exempt: true
• 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: 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	00816389028326 [Unit of Use]
GS1	10816389028323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152018

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

Sterilization

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

[00816389028326]

Moist Heat or Steam Sterilization

[00816389028326]

Moist Heat or Steam Sterilization

[00816389028326]

Moist Heat or Steam Sterilization

[00816389028326]

Moist Heat or Steam Sterilization

[00816389028326]

Moist Heat or Steam Sterilization

[00816389028326]

Moist Heat or Steam Sterilization

[00816389028326]

Moist Heat or Steam Sterilization

[00816389028326]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-27
• Device Publish Date: 2020-11-13

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• 10816389020358 - Transfer Guide Tube + of 500 mm length for catheters: 2024-02-28