MammoSite® Balloon Catheter Accessory Kit GM11008920

GUDID 00816389024755

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389024755
• NIH Device Record Key: 0987d16a-c829-4aff-b395-eedc87a2a965
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MammoSite® Balloon Catheter Accessory Kit
• Version Model Number: GM11008920
• Catalog Number: GM11008920
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00816389024755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141336

FDA Product Code

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

Sterilization

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

[00816389024755]

Moist Heat or Steam Sterilization

[00816389024755]

Moist Heat or Steam Sterilization

[00816389024755]

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

Devices Manufactured by Varian Medical Systems Deutschland GmbH

• 00810563023022 - Titanium Allen wrench: 2025-05-29
• 00816389027961 - Interstitial mini ovoid pair, with fixation for guide tubes: 2025-05-29
• 00816389027978 - Interstitial ovoid pair for 20mm spread, with fixation for guide tubes: 2025-05-29
• 00816389027985 - Interstitial ovoid pair for 25mm spread, with fixation for guide tubes: 2025-05-29
• 00816389027992 - Interstitial ovoid pair for 30mm spread, with fixation for guide tubes: 2025-05-29
• 00810563022933 - Ovoid \ cervical stop set screw (pack of 8): 2025-05-29
• 00810563022612 - Disassembly Pin, CT/ MR: 2025-05-26
• 00816389029439 - CT/ MR Tandem and Ovoid Set (CTO): 2025-05-26