Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin GM11014710

GUDID 20810563021961

Varian Medical Systems Deutschland GmbH

Brachytherapy needle

• Primary Device ID: 20810563021961
• NIH Device Record Key: a9508d29-5fa2-495a-a87e-1819f3b802fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin
• Version Model Number: GM11014710
• Catalog Number: GM11014710
• 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: 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	00810563021967 [Primary]
GS1	10810563021964 [Package]; Contains: 00810563021967; Package: [10 Units]; In Commercial Distribution
GS1	20810563021961 [Package]; Contains: 10810563021964; Package: [20 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

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

Moist Heat or Steam Sterilization

[20810563021961]

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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• 00816389027985 - Interstitial ovoid pair for 25mm spread, with fixation for guide tubes: 2025-05-29
• 00816389027992 - Interstitial ovoid pair for 30mm spread, with fixation for guide tubes: 2025-05-29
• 00810563022933 - Ovoid \ cervical stop set screw (pack of 8): 2025-05-29
• 00810563022612 - Disassembly Pin, CT/ MR: 2025-05-26
• 00816389029439 - CT/ MR Tandem and Ovoid Set (CTO): 2025-05-26