Mandrin for 200 mm length GM11010450

GUDID 10810563022008

Varian Medical Systems Deutschland GmbH

Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle

• Primary Device ID: 10810563022008
• NIH Device Record Key: bf6dd7db-9db6-4e93-aa50-f7dc076ad65d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mandrin for 200 mm length
• Version Model Number: GM11010450
• Catalog Number: GM11010450
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00810563022001 [Primary]
GS1	10810563022008 [Package]; Contains: 00810563022001; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141624

FDA Product Code

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

Sterilization

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

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

[10810563022008]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-26
• Device Publish Date: 2024-02-16

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• 10816389020372 - Transfer Guide Tube + of 1000 mm length for Luer connections: 2024-02-28