Intrauterine tandems, right and left, 320mm, angle 20 x 60mm length GM11009860

GUDID 00810563022124

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00810563022124
• NIH Device Record Key: 61a79f2e-4b2f-48b8-bf46-00859b0bdb90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intrauterine tandems, right and left, 320mm, angle 20 x 60mm length
• Version Model Number: GM11009860
• Catalog Number: GM11009860
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: true
• 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	00810563022124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980576

FDA Product Code

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

Sterilization

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

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

[00810563022124]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-24
• Device Publish Date: 2023-04-16

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• 00810563022438 - Smit cervical sleeves ø 3 mm, 40mm length, with marker: 2024-11-27
• 00810563022445 - Smit cervical sleeves ø 3 mm, 50mm length, with marker: 2024-11-27
• 00810563022452 - Smit cervical sleeves ø 3 mm, 60mm length, with marker: 2024-11-27
• 00810563022469 - Smit cervical sleeves ø 3 mm, 70mm length, with marker: 2024-11-27
• 00810563022476 - Smit cervical sleeves ø 3 mm, 80mm length, with marker: 2024-11-27
• 00810563022483 - Fixation for 3 channel applicators, for adjustable holder: 2024-11-27