Varian POST ASSY, STEREOTACTIC HEAD FRAME

GUDID 10899475002490

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 10899475002490
• NIH Device Record Key: 71db7eda-88ba-47c9-8f32-743b3660bb8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varian POST ASSY, STEREOTACTIC HEAD FRAME
• Version Model Number: 10002738503
• 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: 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	00899475002493 [Primary]
GS1	10899475002490 [Package]; Contains: 00899475002493; Package: Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180586

FDA Product Code

• IYE: Accelerator, linear, medical

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: 2021-03-01
• Device Publish Date: 2021-02-19

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