Surface cone inset, 45 diameter x 25 mm, oval GM11003650

GUDID 00816389022805

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389022805
• NIH Device Record Key: ae29ce65-03aa-47b3-a5da-821b2d5c24f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surface cone inset, 45 diameter x 25 mm, oval
• Version Model Number: GM11003650
• Catalog Number: GM11003650
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• 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 Dimensions

• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter
• Lumen/Inner Diameter: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389022805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162018
• Premarket Notification: K983436

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-23

Devices Manufactured by Varian Medical Systems Deutschland GmbH

• 00816389028067 - Catheter Surface Flap Applicator Set: 2024-11-13
• 00816389028074 - Catheter flap, 200 mm x 290 mm x 10 mm: 2024-11-13
• 00810563021929 - Heyman capsule MR safe, 4 mm diameter x 17.5 mm length, with mandrin: 2024-10-31
• 00810563021936 - Heyman capsule MR safe, 6 mm diameter x 17.5 mm length, with mandrin: 2024-10-31
• 00810563021943 - Heyman capsule MR safe, 8 mm diameter x 17.5 mm length, with mandrin: 2024-10-31
• 00810563022834 - Intraluminal Applicator Set: 2024-10-08 Intraluminal Applicator Set
• 10816389027180 - Protection caps, blue (pack of 20): 2024-05-03
• 10816389027210 - Sterilization plug, black (pack of 25): 2024-05-03