X-ray marker BV, up to 320 mm applicators, uncoded GM11009600

GUDID 00816389024861

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube Brachytherapy system remote afterloading source transfer tube Brachytherapy system remote afterloading source transfer tube

• Primary Device ID: 00816389024861
• NIH Device Record Key: 940fbee8-00fb-4468-8cf2-08888b576fcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-ray marker BV, up to 320 mm applicators, uncoded
• Version Model Number: GM11009600
• Catalog Number: GM11009600
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00816389024861 [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

[00816389024861]

Moist Heat or Steam Sterilization

[00816389024861]

Moist Heat or Steam Sterilization

[00816389024861]

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, up to 320 mm applicators, uncoded]

• 00816389024861: GM11009600
• 00816389029118: GM11009600