Mandrin for 113 mm length GM11010390

GUDID 00810563021998

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: 00810563021998
• NIH Device Record Key: bf8fb2ed-a5db-4ad0-9c8f-a44dbe619a32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mandrin for 113 mm length
• Version Model Number: GM11010390
• Catalog Number: GM11010390
• 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	00810563021998 [Primary]

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

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

Moist Heat or Steam Sterilization

[00810563021998]

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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