Centering Intraluminal Applicator Set GM11009010

GUDID 00816389024779

Varian Medical Systems Deutschland GmbH

Bronchial brachytherapy system applicator, remote-afterloading Bronchial brachytherapy system applicator, remote-afterloading Bronchial brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389024779
• NIH Device Record Key: a7dfb408-e75b-4a43-bce6-21e5486fb4f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centering Intraluminal Applicator Set
• Version Model Number: GM11009010
• Catalog Number: GM11009010
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00816389024779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082653

FDA Product Code

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

Sterilization

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

[00816389024779]

Moist Heat or Steam Sterilization

[00816389024779]

Moist Heat or Steam Sterilization

[00816389024779]

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: 2016-09-22

On-Brand Devices [Centering Intraluminal Applicator Set]

• 00816389024779: GM11009010
• 00816389024748: GM11008890