Aarhus Applicator Set GM11013800

GUDID 00816389028050

Contains: GM11013810-00816389028036, GM11013820-00816389028043

VARIAN MEDICAL SYSTEMS, INC.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389028050
• NIH Device Record Key: 6deed8c4-33ad-44dd-817e-410f9c6181bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aarhus Applicator Set
• Version Model Number: GM11013800
• Catalog Number: GM11013800
• 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	00816389028050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222775

FDA Product Code

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

Sterilization

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

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

[00816389028050]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-10
• Device Publish Date: 2023-03-31

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• 00899475002042 - Clinac iX: 2023-06-20
• 00899475002066 - Trilogy: 2023-06-20
• 00899475002080 - Novalis Tx: 2023-06-20
• 00810563021066 - Embozene Color Advance 40um Embozene 2mL Colored - US: 2023-05-29