Sterilization Tray GM11009940

GUDID 00816389028357

For Universal Endometrial Applicator Set

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389028357
• NIH Device Record Key: 49e66682-59c0-4e8f-843e-ea640f2e3c02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilization Tray
• Version Model Number: GM11009940
• Catalog Number: GM11009940
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• 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: 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	00816389028357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980576

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-27

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