Head Frame Cranial Screws, Long

GUDID 20858086006263

Pouch of 2

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 20858086006263
• NIH Device Record Key: cfa3e5f7-683e-41d8-a474-349963dfab7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Head Frame Cranial Screws, Long
• Version Model Number: P1008070004
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	00858086006269 [Unit of Use]
GS1	10858086006266 [Primary]
GS1	20858086006263 [Package]; Contains: 10858086006266; Package: Box [2 Units]; In Commercial Distribution
GS1	30858086006260 [Package]; Package: Case [10 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: true
• Device Is Sterile: false

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

Moist Heat or Steam Sterilization

[20858086006263]

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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