Stump Applicator Set with CT Cylinders GM11004160

GUDID 00816389023017

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389023017
• NIH Device Record Key: e45b8177-aacd-452b-94c5-48381d17990f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stump Applicator Set with CT Cylinders
• Version Model Number: GM11004160
• Catalog Number: GM11004160
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00816389023017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033371

FDA Product Code

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

Sterilization

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

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

[00816389023017]

Moist Heat or Steam Sterilization

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

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• 00810563021936 - Heyman capsule MR safe, 6 mm diameter x 17.5 mm length, with mandrin: 2024-10-31
• 00810563021943 - Heyman capsule MR safe, 8 mm diameter x 17.5 mm length, with mandrin: 2024-10-31
• 00810563022834 - Intraluminal Applicator Set: 2024-10-08 Intraluminal Applicator Set
• 10816389027180 - Protection caps, blue (pack of 20): 2024-05-03
• 10816389027210 - Sterilization plug, black (pack of 25): 2024-05-03