3D Interstitial Ring Applicator Set 90 degrees GM11010290

GUDID 00810563022247

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00810563022247
• NIH Device Record Key: d4395faa-fed8-433f-8717-77b85bd6f3b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Interstitial Ring Applicator Set 90 degrees
• Version Model Number: GM11010290
• Catalog Number: GM11010290
• 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: 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	00810563022247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150839

FDA Product Code

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

Sterilization

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

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

[00810563022247]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-15
• Device Publish Date: 2023-05-05

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