3D-FSD interstitial ovoid pair for 20mm spread with 4 needle guide holes/ovoid GM11010710

GUDID 00816389025578

For Titanium Fletcher-style Applicator Set Defined Geometry

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389025578
• NIH Device Record Key: 98d9e014-0391-4cf1-a6dd-8c07098dfa97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D-FSD interstitial ovoid pair for 20mm spread with 4 needle guide holes/ovoid
• Version Model Number: GM11010710
• Catalog Number: GM11010710
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• 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	00816389025578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952913

FDA Product Code

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

Sterilization

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

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

[00816389025578]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-10
• Device Publish Date: 2021-02-02

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