X-ray marker BV set II, up to 320 mm applicators, coded 07-12 GM11009630

GUDID 00816389024892

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube

• Primary Device ID: 00816389024892
• NIH Device Record Key: 921a13e4-41b3-4b5d-b6b3-4b10906b19c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-ray marker BV set II, up to 320 mm applicators, coded 07-12
• Version Model Number: GM11009630
• Catalog Number: GM11009630
• 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: 320 Millimeter
• Length: 320 Millimeter
• Length: 320 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389024892 [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

[00816389024892]

Moist Heat or Steam Sterilization

[00816389024892]

Moist Heat or Steam Sterilization

[00816389024892]

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 320 mm applicators, coded 07-12]

• 00816389024892: GM11009630
• 00816389029149: GM11009630