Flexible Fixation Device for Gynecological Applicators GM11001960

GUDID 00816389029057

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389029057
• NIH Device Record Key: e0ae2021-5c08-4792-8c38-61dd1dce6e52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Fixation Device for Gynecological Applicators
• Version Model Number: GM11001960
• Catalog Number: GM11001960
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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	00816389029057 [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

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

[00816389029057]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-18
• Device Publish Date: 2021-10-10

On-Brand Devices [Flexible Fixation Device for Gynecological Applicators]

• 00816389022119: GM11001960
• 00816389029057: GM11001960