Pair of Titanium colpostat tandem (left & right) AL07523000

GUDID 00816389020894

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389020894
• NIH Device Record Key: 186276b4-d665-4717-902a-657fdb640fae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pair of Titanium colpostat tandem (left & right)
• Version Model Number: AL07523000
• Catalog Number: AL07523000
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00816389020894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952913

FDA Product Code

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

Sterilization

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

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

[00816389020894]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

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• 00810563021882 - Ring probe (2021), Ø 26 x 60°: 2025-04-03
• 00810563021899 - Ring probe (2021), Ø 30 x 60°: 2025-04-03
• 00810563021905 - Ring probe (2021), Ø 26 x 90°: 2025-04-03
• 00810563021912 - Ring probe (2021), Ø 30 x 90°: 2025-04-03
• 00810563022841 - Fixation ring for cylinder ø 20 mm: 2025-04-03
• 00810563022858 - Fixation ring for cylinder ø 23 mm: 2025-04-03