Guided Aarhus vaginal template 60 degrees, ø 36 mm GM11013930

GUDID 00816389028968

VARIAN MEDICAL SYSTEMS, INC.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389028968
• NIH Device Record Key: cb2c1d68-d8d0-4411-b73f-3540940e1a51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guided Aarhus vaginal template 60 degrees, ø 36 mm
• Version Model Number: GM11013930
• Catalog Number: GM11013930
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00816389028968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252884

FDA Product Code

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

Sterilization

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

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

[00816389028968]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-03
• Device Publish Date: 2025-11-25

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

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• 00816389028951 - Guided Aarhus vaginal template 60 degrees, ø 32 mm: 2025-12-03
• 00816389028968 - Guided Aarhus vaginal template 60 degrees, ø 36 mm: 2025-12-03
• 00816389028968 - Guided Aarhus vaginal template 60 degrees, ø 36 mm: 2025-12-03
• 00816389028975 - Guide tube collector for up to 7 needles: 2025-12-03
• 00816389028982 - Guide tube collector for up to 11 needles: 2025-12-03
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