HeadFrame Kit, Couch Adapter, SCCB Kit, & 20 Short + 20 Long Head Screws

GUDID 00858086006313

Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long; one 00858086006252 Headframe Kit; and one Couch Adapter

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 00858086006313
• NIH Device Record Key: f7d39d18-e2da-4ba1-aa93-cb5e6390339f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeadFrame Kit, Couch Adapter, SCCB Kit, & 20 Short + 20 Long Head Screws
• Version Model Number: P1006805006
• 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: 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	00858086006313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180586

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

[00858086006313]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-25
• Device Publish Date: 2021-01-16

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00810563022957 - Titanium Flexible Geometry FSD Applicator Set: 2025-05-30
• 00810563022995 - Ovoid pair, mini ø 16 mm: 2025-05-30
• 00810563023008 - Ovoid mini Ø16 mm Left: 2025-05-30
• 00810563023015 - Ovoid mini Ø16 mm Right: 2025-05-30
• 00855141006417 - MaximQA: 2025-03-12
• 00858086006818 - IDENTIFY: 2025-03-05
• 30816389027290 - Fixation buttons, pack of 10, sterile: 2025-02-21
• 00855141006349 - Eclipse Treatment Planning System: 2024-12-30