VARIAN HEAD FRAME KIT P1006805003

GUDID 00899475002394

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 00899475002394
• NIH Device Record Key: c0e35e06-c127-45c4-861c-e6a125e92135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARIAN HEAD FRAME KIT
• Version Model Number: 2.0
• Catalog Number: P1006805003
• 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: false
• Serial Number: true
• 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	00899475002394 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-16
• Device Publish Date: 2018-05-15

On-Brand Devices [VARIAN HEAD FRAME KIT]

• 00899475002189: Head Frame Kit w/20 Short + 20 Long Cranial Screws
• 00899475002394: 2.0