X-ray marker BV set II, up to 500 mm tubes, coded 07-12 GM11009680

GUDID 00816389024946

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube

• Primary Device ID: 00816389024946
• NIH Device Record Key: e036483f-fa08-4e95-bfe1-cf0db95f4366
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-ray marker BV set II, up to 500 mm tubes, coded 07-12
• Version Model Number: GM11009680
• Catalog Number: GM11009680
• 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

• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389024946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983436

FDA Product Code

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

Sterilization

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

[00816389024946]

Moist Heat or Steam Sterilization

[00816389024946]

Moist Heat or Steam Sterilization

[00816389024946]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [X-ray marker BV set II, up to 500 mm tubes, coded 07-12]

• 00816389024946: GM11009680
• 00816389029194: GM11009680