3D FSD interstitial ovoid pair for 25 mm spread GM11010720

GUDID 00810563022537

3D FSD interstitial ovoid pair for 25 mm spread, with 6 needle guide holes each ovoid

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00810563022537
• NIH Device Record Key: 7ede8987-0b6f-4b41-bb40-05b6c4695ed0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D FSD interstitial ovoid pair for 25 mm spread
• Version Model Number: GM11010720
• Catalog Number: GM11010720
• 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: 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	00810563022537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241853

FDA Product Code

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

Sterilization

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

[00810563022537]

Moist Heat or Steam Sterilization

[00810563022537]

Moist Heat or Steam Sterilization

[00810563022537]

Moist Heat or Steam Sterilization

[00810563022537]

Moist Heat or Steam Sterilization

[00810563022537]

Moist Heat or Steam Sterilization

[00810563022537]

Moist Heat or Steam Sterilization

[00810563022537]

Moist Heat or Steam Sterilization

[00810563022537]

Moist Heat or Steam Sterilization

[00810563022537]

Moist Heat or Steam Sterilization

[00810563022537]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-27
• Device Publish Date: 2024-11-19

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• 00810563022452 - Smit cervical sleeves ø 3 mm, 60mm length, with marker: 2024-11-27
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• 00810563022483 - Fixation for 3 channel applicators, for adjustable holder: 2024-11-27