3D Interstitial Ring Applicator Set 60 degrees GM11010190

GUDID 00816389025226

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389025226
• NIH Device Record Key: 3dc700c2-fc9d-454a-9496-bf2a35aba183
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Interstitial Ring Applicator Set 60 degrees
• Version Model Number: GM11010190
• Catalog Number: GM11010190
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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	00816389025226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150839

FDA Product Code

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

Sterilization

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

[00816389025226]

Moist Heat or Steam Sterilization

[00816389025226]

Moist Heat or Steam Sterilization

[00816389025226]

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 [3D Interstitial Ring Applicator Set 60 degrees]

• 00816389025226: GM11010190
• 00810563022230: GM11010190