X-ray marker BV set II, up to 200 mm needles, coded 07-12 GM11009650

GUDID 00816389029163

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube

• Primary Device ID: 00816389029163
• NIH Device Record Key: e94af798-dbc9-4d07-8c1a-ab5787bbe1d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-ray marker BV set II, up to 200 mm needles, coded 07-12
• Version Model Number: GM11009650
• Catalog Number: GM11009650
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00816389029163 [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

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

[00816389029163]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-25
• Device Publish Date: 2021-11-17

On-Brand Devices [X-ray marker BV set II, up to 200 mm needles, coded 07-12]

• 00816389024915: GM11009650
• 00816389029163: GM11009650