GammaMed Plus GM+ HDR Ir 192 Brachytherapy Sealed Source GM12000680

GUDID 00816389028838

Varian Medical Systems Deutschland GmbH

Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source

• Primary Device ID: 00816389028838
• NIH Device Record Key: 30a9afa1-e06d-434b-808b-7748ef8c002a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GammaMed Plus GM+ HDR Ir 192 Brachytherapy Sealed Source
• Version Model Number: GM12000680
• Catalog Number: GM12000680
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• 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	00816389028838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030745

FDA Product Code

• KXK: Source, brachytherapy, radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-17
• Device Publish Date: 2022-01-09

Devices Manufactured by Varian Medical Systems Deutschland GmbH

• 10816389027180 - Protection caps, blue (pack of 20): 2024-05-03
• 10816389027210 - Sterilization plug, black (pack of 25): 2024-05-03
• 10816389024646 - Flexible implant tube, double leader, 530 mm, sterile, set of 3: 2024-04-19
• 10816389020310 - Transfer Guide Tube + for 320 mm applicators: 2024-02-28
• 10816389020327 - Transfer Guide Tube + of 1000 mm length for applicators: 2024-02-28
• 10816389020334 - Transfer Guide Tube + for 200 mm catheters: 2024-02-28
• 00816389020344 - Transfer Guide Tube + for 250 mm catheters: 2024-02-28
• 10816389020358 - Transfer Guide Tube + of 500 mm length for catheters: 2024-02-28