Blank templates, size D-48 mm x 70 mm AL07349021

GUDID 00816389020719

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389020719
• NIH Device Record Key: fc793578-568e-4759-9dd0-627a811a9cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blank templates, size D-48 mm x 70 mm
• Version Model Number: AL07349021
• Catalog Number: AL07349021
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: false
• 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: 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	00816389020719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023220

FDA Product Code

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

Sterilization

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

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

[00816389020719]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-19

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• 00810563021875 - Ring probe (2021), Ø 30 x 45°: 2025-04-03
• 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