Head Frame - Post Assembly Set

GUDID 00858086006290

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 00858086006290
• NIH Device Record Key: a3bbcaff-bd6b-4734-8010-5c4036609d72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Head Frame - Post Assembly Set
• Version Model Number: P1008016004
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 4
• 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	00858086006290 [Unit of Use]
GS1	10858086006297 [Primary]
GS1	20858086006294 [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

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

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

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