Source Guide Tube Set for third-party-applicators, GammaMedplus GM11008730

GUDID 00816389024717

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389024717
• NIH Device Record Key: 5e4532b4-4ae5-4669-9d74-ea18a58abfdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Source Guide Tube Set for third-party-applicators, GammaMedplus
• Version Model Number: GM11008730
• Catalog Number: GM11008730
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• 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	00816389024717 [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

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

[00816389024717]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-10
• Device Publish Date: 2021-02-02

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00856100006158 - Visual Coaching Device (VCD): 2023-11-22
• 00850800006067 - VariSeed: 2023-09-25
• 00858086006801 - IDENTIFY: 2023-08-14
• 00855141006202 - Eclipse Treatment Planning System: 2023-08-07
• 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